Original Article
Reduced Exposure to Calcineurin Inhibitors in Renal Transplantation
N Engl J Med 2007; 357:2562-2575December 20, 2007
- Abstract
Background
Immunosuppressive regimens with the fewest possible toxic effects are desirable for transplant recipients. This study evaluated the efficacy and relative toxic effects of four immunosuppressive regimens.
Methods
We randomly assigned 1645 renal-transplant recipients to receive standard-dose cyclosporine, mycophenolate mofetil, and corticosteroids, or daclizumab induction, mycophenolate mofetil, and corticosteroids in combination with low-dose cyclosporine, low-dose tacrolimus, or low-dose sirolimus. The primary end point was the estimated glomerular filtration rate (GFR), as calculated by the Cockcroft–Gault formula, 12 months after transplantation. Secondary end points included acute rejection and allograft survival.
Results
The mean calculated GFR was higher in patients receiving low-dose tacrolimus (65.4 ml per minute) than in the other three groups (range, 56.7 to 59.4 ml per minute). The rate of biopsy-proven acute rejection was lower in patients receiving low-dose tacrolimus (12.3%) than in those receiving standard-dose cyclosporine (25.8%), low-dose cyclosporine (24.0%), or low-dose sirolimus (37.2%). Allograft survival differed significantly among the four groups (P=0.02) and was highest in the low-dose tacrolimus group (94.2%), followed by the low-dose cyclosporine group (93.1%), the standard-dose cyclosporine group (89.3%), and the low-dose sirolimus group (89.3%). Serious adverse events were more common in the low-dose sirolimus group than in the other groups (53.2% vs. a range of 43.4 to 44.3%), although a similar proportion of patients in each group had at least one adverse event during treatment (86.3 to 90.5%).
Conclusions
A regimen of daclizumab, mycophenolate mofetil, and corticosteroids in combination with low-dose tacrolimus may be advantageous for renal function, allograft survival, and acute rejection rates, as compared with regimens containing daclizumab induction plus either low-dose cyclosporine or low-dose sirolimus or with standard-dose cyclosporine without induction. (ClinicalTrials.gov number, NCT00231764.)
Media in This Article
Figure 1
Enrollment and Outcomes.Figure 2
Mean Trough Levels of Cyclosporine, Tacrolimus, and Sirolimus, According to Study Group.Article Activity
- Article
Despite improved short-term outcome in renal transplantation, 3 to 5% of allografts per year are still lost; the leading causes are long-term allograft nephropathy and death with a functioning allograft.1 As patients have fewer acute rejection episodes, adverse events associated with long-term immunosuppression have become increasingly evident. Accordingly, reducing the toxic effects of immunosuppressive regimens has become a major goal in the treatment of transplant recipients.
Cyclosporine, a calcineurin inhibitor in use for many years, is still the basis of many immunosuppressive regimens because of its clinical success. However, standard recommended doses are associated with nephrotoxicity, resulting in long-term renal dysfunction,2 hypertension, and hyperlipidemia.3-6 In one report, virtually all 99 recipients of kidney–pancreas transplants who received cyclosporine-based immunosuppression had nephrotoxicity 10 years after transplantation, with the median onset of the first lesion at 6 months.7 Tacrolimus, a more recently introduced calcineurin inhibitor, is reportedly more effective than cyclosporine at improving allograft survival and preventing acute rejection at 1 year.8 However, at currently recommended doses, tacrolimus shares many side effects with cyclosporine, including nephrotoxicity, neurotoxicity, infectious complications, and disturbances in lipid metabolism.9,10 Sirolimus, recently introduced, is as effective as cyclosporine11,12 but is associated with delayed wound healing,13 formation of lymphoceles,14 and an increased incidence of several other adverse events (including hyperlipidemia,11 thrombocytopenia,12 and diarrhea), as compared with cyclosporine.12
Accordingly, immunosuppressive regimens that would permit dose reductions of these calcineurin inhibitors and sirolimus would be attractive, provided that adequate immunosuppression and acceptable rates of acute rejection were preserved. The Efficacy Limiting Toxicity Elimination (ELITE)–Symphony study was initiated to assess whether a mycophenolate mofetil–based regimen would permit the administration of lower doses of adjunct immunosuppressive agents (e.g., cyclosporine, tacrolimus, and sirolimus), yet still maintain an acceptable rate of acute rejection and a more favorable tolerability profile. Unlike many other studies that have evaluated immunosuppressive regimens, our trial used low-dose maintenance levels of cyclosporine, tacrolimus, or sirolimus from the day of transplantation. The study design was based on standard clinical procedures in common use internationally, a factor that allowed many patients to meet the criteria for study entry.
Methods
Study Design and Patients
We carried out a 12-month, prospective, randomized, open-label, multicenter study in four parallel groups of adult renal-transplant recipients in compliance with the provisions of the Declaration of Helsinki and Good Clinical Practice guidelines. All patients provided written informed consent and could withdraw from the study at any time.
The trial was proposed and designed by the first and last authors, who obtained funding and ran the trial, along with steering committee members, who had complete access to the data for review of the analysis and controlled the decision to publish. Funding for the study was provided by Hoffmann–La Roche, which had advisory input into the study design, collected the data, monitored the conduct of the study, performed the statistical analyses, and coordinated the writing of the manuscript with all authors. The first author had access to the complete study data, and vouches for the veracity and completeness of the data and the data analyses. Representatives of Hoffmann–La Roche had the opportunity to review and comment on all versions of the manuscript.
Patients between the ages of 18 and 75 years who were scheduled to receive a single-organ renal transplant from either a living donor or a deceased donor were eligible. Patients receiving a second renal transplant were eligible, provided that the first allograft was not lost owing to acute rejection within the first year after transplantation. Exclusion criteria included the need for treatment with azathioprine, methotrexate or cyclophosphamide, polyclonal or monoclonal antilymphocyte antibodies, basiliximab, or any investigational drug; a current or historic panel-reactive antibody titer of more than 20%; a positive cross-match; a cold-ischemia time of more than 30 hours for the allograft; receipt of an allograft from a deceased donor without a heartbeat; a gastrointestinal disorder that might interfere with the ability to absorb oral medication; a history of cancer, except successfully treated, localized nonmelanocytic skin cancer; active peptic ulcer; evidence of active liver disease; severe anemia, leukopenia, or thrombocytopenia; the receipt of a new investigational drug within the previous 3 months; and previous treatment with daclizumab or basiliximab.
Patients were randomly assigned in a 1:1:1:1 ratio to one of four treatment groups: the standard-dose cyclosporine group, which received a standard dose of cyclosporine (Neoral or Sandimmune, Novartis), mycophenolate mofetil (CellCept, Hoffmann–La Roche), and corticosteroids; the low-dose cyclosporine group, which received daclizumab (Zenapax, Hoffmann–La Roche) during the first 2 months after transplantation and a low dose of cyclosporine, mycophenolate mofetil, and corticosteroids; the low-dose tacrolimus group, which received daclizumab during the first 2 months after transplantation and a low dose of tacrolimus (Prograf, Astellas Pharma), mycophenolate mofetil, and corticosteroids; and the low-dose sirolimus group, which received daclizumab during the first 2 months after transplantation and a low dose of sirolimus (Rapamune, Wyeth), mycophenolate mofetil, and corticosteroids.
Randomization was stratified according to the local participating center and the presence or absence of a donor with expanded criteria.15 Patients underwent randomization before scheduled renal transplantation with the use of a centralized interactive voice-response system (ClinIT). A minimization algorithm was used to optimize the balance of characteristics of patients in study groups, overall and across the strata.
Intravenous daclizumab was infused during a period of 15 to 20 minutes at a dose of 2 mg per kilogram of body weight within 24 hours before transplantation, followed by four doses of 1 mg per kilogram every 2 weeks. The first doses of mycophenolate mofetil, cyclosporine, tacrolimus, and sirolimus were administered within 24 hours before or after transplantation. All groups received oral mycophenolate mofetil at a dose of 2 g per day. In the standard-dose cyclosporine group, the initial oral dose of 3 to 5 mg per kilogram twice daily was adjusted to achieve a target trough level of 150 to 300 ng per milliliter for the first 3 months and 100 to 200 ng per milliliter thereafter. Target trough cyclosporine levels in the low-dose cyclosporine group were 50 to 100 ng per milliliter throughout the study; the initial oral dose was 1 to 2 mg per kilogram twice daily. In the low-dose tacrolimus group, the initial dose of oral tacrolimus of 0.1 mg per kilogram per day divided into two daily doses was adjusted to achieve a target trough level of 3 to 7 ng per milliliter. In the low-dose sirolimus group, patients received oral sirolimus at a dose of 9 mg per day for 3 days and 3 mg per day thereafter, adjusted to achieve trough levels of 4 to 8 ng per milliliter. All patients received intraoperative and maintenance corticosteroids according to the practice at the center. The minimum maintenance corticosteroid doses were 20 mg of prednisone (or the equivalent) for the first 2 weeks after transplantation, 15 mg from week 3 to week 8, 10 mg from week 9 until the end of month 4, and 5 mg thereafter.
Blood levels of cyclosporine, tacrolimus, and sirolimus were measured with the use of locally available assays. On the basis of information from 60 of 83 sites, the most commonly used assays were TDx (Abbott Diagnostics) for cyclosporine (used at 33.3% of sites), IMx (Abbott Diagnostics) for tacrolimus (used by 65.0%), and high-performance liquid chromatography with ultraviolet detection for sirolimus (used by 61.7%).
Efficacy
The primary end point was the estimated glomerular filtration rate (GFR) 12 months after transplantation, calculated from serum creatinine measures with the use of the Cockcroft–Gault formula.16 Secondary efficacy end points included renal function as indicated by the calculated GFR during the course of the study, measured GFR at 12 months, acute rejection, overall survival and allograft survival at 6 and 12 months, time to the first episode of acute rejection, the frequency of treatment failure during the first 12 months, and the incidence of delayed allograft function. Treatment failure was defined as the occurrence of any of the following: the use of additional immunosuppressive medication, the discontinuation of any study medication for more than 14 consecutive days or more than 30 cumulative days, allograft loss, or death.
Safety
Safety was evaluated by clinical assessment including vital signs and laboratory analyses designed to determine the incidence of adverse events, opportunistic infections, cancer, and death throughout the study; the incidence of failure to achieve primary closure of the transplant surgical wound at 2 weeks; and the formation of lymphoceles requiring intervention within 6 months after transplantation.
Statistical Analysis
The original protocol called for the enrollment of 1300 patients. In an amendment to the protocol, this number was increased to 1760 patients (440 per group) to provide a power of 80% to detect a difference of 6.5 ml per minute in GFR in one group with respect to the others in a global test, a value that was considered to be clinically relevant by the study's steering committee. To calculate the GFR, a last-observation-carried-forward method was used for serum creatinine and weight, and 10 ml per minute was imputed for missing values.
The primary method used to compare the study groups was an analysis of variance including factors for treatment, center, and donors with expanded criteria and other factors. Since the model, even after variable transformations, markedly violated the assumptions for normality (as judged by the study statistician after inspection of diagnostic plots and by the rejection of normality assumption with the use of the Shapiro–Wilk test at the 10% level), we performed overall group comparisons with the use of the Kruskal–Wallis test, followed by pairwise comparisons with the Wilcoxon rank-sum test in case of significance at the 5% level. Time to biopsy-proven acute rejection, allograft loss, treatment failure, and death were analyzed with the use of the Kaplan–Meier method, and group differences were assessed by the log-rank test.
Groups of patients that underwent analysis included a safety population (patients who received at least one dose of a study drug) and an intention-to-treat population (patients who received at least one dose of a study drug and underwent transplantation). Patients who were prematurely withdrawn from the study were followed for data collection whenever possible.
The incidence of all adverse events and serious adverse events are reported as frequencies in the safety population. However, the number of patients at risk for an event varied with time, owing to the variation in premature withdrawal in the study groups. Therefore, additional Kaplan–Meier analyses were performed for selected adverse events known to be associated with immunosuppressive drugs,9,12,14 including new-onset diabetes after transplantation, diarrhea, the formation of lymphoceles, opportunistic infections, and cytomegalovirus infection.
Results
Patients
From November 2002 to November 2004, a total of 1645 patients from 83 sites in 15 countries underwent randomization (Figure 1Figure 1
Enrollment and Outcomes.). Although the recruitment target of 1760 was not met by the end of the planned enrollment period, the duration of recruitment was not extended for operational reasons. The groups were well balanced with respect to demographic, clinical, and donor–recipient characteristics, with no significant between-group differences (Table 1Table 1
Baseline Characteristics of the Patients.). Withdrawal from assigned treatment ranged from 20.0% in the low-dose tacrolimus group to 48.9% in the low-dose sirolimus group (Figure 1). In all groups, treatment failure was the main reason for withdrawal. The use of additional immunosuppressive drugs (in 7.5 to 30.3% of patients, depending on the group) and the discontinuation of a study drug (in 16.4 to 24.6% of patients, depending on the group) were the main categories of treatment failure in the four study groups. Acute rejection was not explicitly included as one of the possible reasons for treatment failure.Target trough levels for immunosuppression were generally met (Figure 2Figure 2
Mean Trough Levels of Cyclosporine, Tacrolimus, and Sirolimus, According to Study Group.). Mean (±SD) levels were mainly at the upper end of the target range. Mean daily doses of corticosteroids (or prednisone equivalent) during the first year were 16.3±13.1 mg (in the standard-dose cyclosporine group), 14.2±14.2 mg (in the low-dose cyclosporine group), 13.5±10.0 mg (in the low-dose tacrolimus group), and 17.7±14.1 mg (in the low-dose sirolimus group). These doses were higher in the standard-dose cyclosporine group and the low-dose sirolimus group than in the low-dose tacrolimus group (P=0.01 and P<0.001, respectively) and higher in the low-dose sirolimus group than in the low-dose cyclosporine group (P<0.001).Efficacy Measurements
GFR
Twelve months after transplantation, renal function differed significantly among the four groups (P<0.001 for the overall group comparison). The estimated GFR was higher in the low-dose tacrolimus group than in the other study groups (P<0.001 for the comparisons with the standard-dose cyclosporine group and the low-dose sirolimus group and P=0.001 for the comparison with the low-dose cyclosporine group) (Table 2Table 2
Primary End Point and Selected Secondary End Points.). The mean estimated GFR remained relatively stable from about 8 weeks onward.Acute Rejection
At 6 and 12 months, the incidence of biopsy-proven acute rejection (excluding borderline cases) in the low-dose tacrolimus group was approximately half those in the standard-dose cyclosporine group and the low-dose cyclosporine group and approximately one third that in the low-dose sirolimus group (P<0.001 for all pairwise comparisons with low-dose tacrolimus) (Figure 3AFigure 3
Cumulative Probability of Biopsy-Proven Acute Rejection (Panel A) and Allograft Survival (Panel B), According to Study Group. and Table 2). At 12 months, the proportions of patients with clinically suspected, treated episodes of acute rejection were similar to those of biopsy-proven acute rejection (P<0.001 for all pairwise comparisons with low-dose tacrolimus) (Table 2).Overall Survival and Allograft Survival
Allograft survival in the low-dose tacrolimus group was significantly higher than in the standard-dose cyclosporine group and the low-dose sirolimus group (P=0.007 for both comparisons) (Table 2 and Figure 3B). Overall survival rates for patients were more than 96% in all groups without significant differences (Table 2).
Treatment Failure
Treatment failure was lowest in the low-dose tacrolimus group (12.2%) and highest in the low-dose sirolimus group (35.8%, P<0.001) (Table 2). Treatment failure as a result of discontinuation of any assigned immunosuppressive agent for more than 14 consecutive days leading to withdrawal was 4.5% in the low-dose tacrolimus group, as compared with 5.1 to 6.8% in the other study groups. Treatment failure as a result of the use of additional maintenance immunosuppressive medication was 1.5% in the low-dose tacrolimus group, as compared with 6.0 to 14.8% in the other study groups. Overall, the rate of treatment failure was 44.0% in patients who had acute rejection, as compared with 13.7% in those who did not have acute rejection in the intention-to-treat population.
Delayed Allograft Function
Among recipients of a kidney from a deceased donor, the incidence of delayed allograft function at 2 weeks (defined as persistent oliguria, a decrease in the serum creatinine level of less than 0.5 mg per deciliter within 24 hours after transplantation, or the institution of dialysis) was lower in the low-dose sirolimus group than in the low-dose tacrolimus group (P=0.001) (Table 2).
Safety
Serious adverse events were reported by 53.2% of patients in the low-dose sirolimus group, as compared with 43.4 to 44.3% in the other study groups (P<0.05 for all comparisons and for between-group comparisons with low-dose sirolimus). In a similar way, 7.8% of patients in the low-dose sirolimus group withdrew from treatment because of an adverse event or a coexisting illness, as compared with 1.8 to 3.1% in the other study groups (Figure 1). A similar proportion of patients in each group had at least one adverse event during the study (86.3 to 90.5%).
The most common adverse events according to body system for all groups were disorders of the blood or lymphatic systems, gastrointestinal disorders, infections or infestations, and metabolism and nutrition disorders (Table 3Table 3
Adverse Events and Serious Adverse Events.).There was a significant between-group difference in the Kaplan–Meier estimates for new-onset diabetes after transplantation at 12 months (P=0.02 for all comparisons), with the highest rate occurring in the low-dose tacrolimus group (Table 3). The proportion of patients who required antidiabetes medication at 3 months after the onset of diabetes ranged from 1.0 to 2.7%, depending on the study group. The Kaplan–Meier estimates for diarrhea differed significantly between the groups (P<0.001), with the lowest rates occurring in the two cyclosporine groups. With respect to the formation of lymphoceles, the rates also differed significantly among the groups (P<0.001), with at least twice as many events in the low-dose sirolimus group as in the other groups. In addition, the proportion of patients who had delayed wound healing 2 weeks after transplantation differed significantly among the study groups (P=0.006 by the chi-square test), with more patients in the low-dose sirolimus group having delayed healing than in the other groups (Table 3).
There was a significant between-group difference in the Kaplan–Meier estimates for opportunistic infections (P=0.03) and cytomegalovirus infection (P=0.003), the latter being the most common opportunistic infection (Table 3). Opportunistic infections, including cytomegalovirus infection, were generally more common in the standard-dose cyclosporine group than in the other groups. Although there was no stratification according to donor–recipient status for cytomegalovirus, there was no significant between-group difference in the proportion of cytomegalovirus-positive donors to cytomegalovirus-negative patients (Table 1).
Cancer developed in four to nine patients in the various study groups within the first 12 months (Table 3). There were 13 deaths in the standard-dose cyclosporine group, and 7, 11, and 12 deaths in the low-dose cyclosporine group, the low-dose tacrolimus group, and the low-dose sirolimus group, respectively. Deaths were preceded by treatment failure in one patient in the standard-dose cyclosporine group, two patients in the low-dose cyclosporine group, one patient in the low-dose tacrolimus group, and one patient in the low-dose sirolimus group. Four deaths were caused by adverse events or coexisting illnesses: two in the standard-dose cyclosporine group and one each in the low-dose cyclosporine group and the low-dose tacrolimus group.
Discussion
The primary objective of our study was to reduce nephrotoxicity with the use of low doses of calcineurin inhibitors or sirolimus. Accordingly, the primary end point was renal function. Secondary objectives were to reduce overall toxic effects while maintaining efficacy in terms of acute rejection, overall survival of patients, and allograft survival.
In an initial trial conducted by members of our group, the avoidance of calcineurin inhibitors with the use of mycophenolate mofetil, daclizumab, and corticosteroids resulted in excellent rates of overall and allograft survival at 12 months (97% and 96%, respectively) but had an unacceptably high rate of biopsy-proven acute rejection (53%).17 Accordingly, the subsequent Cyclosporine Avoidance Eliminates Serious Adverse Renal Toxicity (CAESAR) study was designed with the addition of low-dose cyclosporine, either continuously administered or tapered and withdrawn at 4 to 6 months.18
Our findings represent a further development of strategies for reducing the burden of side effects. With the addition not only of low-dose cyclosporine but also of either low-dose tacrolimus or low-dose sirolimus to the combination of daclizumab, mycophenolate mofetil, and corticosteroids, our study aimed to reduce the rate of biopsy-proven acute rejection from the previously reported rate of 53%.17 In both the CAESAR study18 and our study, patients receiving low-dose cyclosporine had rates of biopsy-proven acute rejection and of mean GFR at 12 months similar to those of patients receiving standard-dose cyclosporine. Thus, reduced doses of cyclosporine did not improve renal function, and further reductions in cyclosporine exposure (to trough levels <50 ng per milliliter) would probably not provide adequate immunosuppression. However, it is possible that optimizing the exposure to mycophenolate mofetil through therapeutic drug monitoring could improve rates of acute rejection and allograft function in a cyclosporine-based regimen.
In our study, the low-dose sirolimus regimen resulted in rates of biopsy-proven acute rejection that were higher than those in the other regimens, and there was no improvement in renal function, as compared with the cyclosporine-containing regimens. This latter result contrasts with the findings of Flechner et al.,19 which showed no significant differences in efficacy but significantly better rates of renal function at 2 years and lower rates of long-term allograft nephropathy in patients receiving standard-dose sirolimus than in those receiving standard-dose cyclosporine, both in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids. However, the study by Flechner et al. was a single-center study involving only 61 patients who received higher doses of sirolimus (trough level, 10 to 12 ng per milliliter during the first 6 months and 5 to 10 ng per milliliter thereafter) than did patients in our study (trough level, 4 to 8 ng per milliliter). It is possible that the sirolimus dose in our study was too low to provide adequate immunosuppression in the period immediately after transplantation. Nonetheless, biopsy-proven acute rejection did not reach the 53% level seen with the protocol calling for the administration of daclizumab, mycophenolate mofetil, and corticosteroids.17 Therefore, the addition of low-dose sirolimus had some efficacy, even though it did not eliminate side effects. It is also possible that the combination of sirolimus and mycophenolate mofetil is inadequate for preventing acute rejection. Two multicenter studies in renal-transplant patients receiving standard doses of sirolimus, mycophenolate mofetil, and corticosteroids, used in combination with interleukin-2 receptor antibody induction, were recently terminated early because of an increased risk of rejection.20
New-onset diabetes is an important concern after organ transplantation and appears to be related to the use of immunosuppressive drugs that impair glucose tolerance, such as tacrolimus and corticosteroids. Given the superior rates of biopsy-proven acute rejection associated with the tacrolimus regimen in our study, it may be possible to reduce the risk of new-onset diabetes after transplantation further by a reduction in the exposure to corticosteroids. For example, in a 6-month trial involving 538 renal-transplant recipients, those receiving tacrolimus, mycophenolate mofetil, and daclizumab had a significantly lower incidence of new-onset diabetes after transplantation than did those receiving tacrolimus, mycophenolate mofetil, and corticosteroids (0.4% vs. 5.4%, P=0.003).21
In conclusion, in our study involving kidney-transplant recipients, treatment for 12 months with a regimen containing daclizumab, mycophenolate mofetil, corticosteroids, and low-dose tacrolimus provided adequate immunosuppression with better renal function and less acute rejection, as compared with daclizumab induction plus low-dose cyclosporine or low-dose sirolimus-containing regimens or to a regimen containing standard-dose cyclosporine without daclizumab induction. In addition, the low-dose tacrolimus regimen provided better allograft survival than did regimens with standard-dose cyclosporine or low-dose sirolimus.
Supported by Hoffmann–La Roche.
Dr. Ekberg reports receiving consulting fees from Hoffmann–La Roche, Novartis, Wyeth, and Astellas and lecture fees from Hoffmann–La Roche and Astellas; Dr. Tedesco-Silva, consulting and lecture fees from Novartis and grant support from Novartis, Wyeth, and Astellas; Dr. Vítko, consulting fees from Astellas, Wyeth, and Ivax Pharmaceuticals and lecture fees from Wyeth, Astellas, and Hoffmann–La Roche; Dr. Nashan, consulting fees from Viron, Hoffmann–La Roche, Novartis, Wyeth, Fujisawa Pharmaceutical, and Astellas, lecture fees from Novartis, Hoffmann–La Roche, and Wyeth, and grant support from CFI, Novartis, and the Nova Scotia Health Research Foundation; Dr. Margreiter, lecture fees from Hoffmann–La Roche; Dr. Hugo, consulting fees from Wyeth, lecture fees from Wyeth, Hoffmann–La Roche, and Johnson & Johnson, and grant support from Wyeth, Novartis, German Research Foundation, and Interdisciplinary Center of Clinical Research; Dr. Grinyó, lecture and consulting fees from Hoffmann–La Roche; Dr. Frei, consulting and lecture fees from Hoffmann–La Roche and Novartis; Dr. Vanrenterghem, consulting fees from Janssen-Cilag, lecture fees from Hoffmann–La Roche and Astellas, and grant support from Amgen, Astellas, Baxter International, and Novartis; Dr. Halloran, holding two provisional patents on tissue rejection, receiving consulting and lecture fees from Roche and grant support from Roche Molecular Systems, Alberta Innovation and Science, and Genome Canada. No other potential conflict of interest relevant to this article was reported.
We thank Christa Silberbauer, the ELITE–Symphony project leader, for her great contributions to the study; Corrado Bernasconi for providing statistical support; Peter Wijngaard, Jana Nöldeke, and Carolyn Sutter, representatives of Hoffmann–La Roche, for their support; Richard Glover of Wolters Kluwer Health for assistance in the preparation of the manuscript; Peter Morris, Daniel Abramowicz, and Gerhard Opelz (chair) of the data and safety monitoring board; and the study investigators and coordinators from the 15 participating countries (Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Germany, Greece, Israel, Mexico, Poland, Spain, Sweden, Turkey, and the United Kingdom) for all their hard work in making this study possible.
Source Information
From Lund University, Malmö, Sweden (H.E.); Federal University, São Paulo (H.T.-S.); Akdeniz University, Antalya, Turkey (A.D.); Institutu Klinické a Experimentální Medicíny, Prague, Czech Republic (S.V.); Medizinische Hochschule, Hannover, Germany (B.N.); S.B. Tepecik Hospital, Izmir, Turkey (A.G.); Universitaetsklinik, Innsbruck, Austria (R.M.); University Hospital, Erlangen, Germany (C.H.); Ciutat Universitaria de Bellvitge, Barcelona (J.M.G.); Charité, Virchow-Klinikum, Berlin (U.F.); Katholieke Universiteit Leuven, Leuven, Belgium (Y.V.); Notre-Dame Hospital, Centre Hospitalier de l'Université de Montréal, Montreal (P.D.); and University of Alberta, Edmonton, Canada (P.F.H.).
Address reprint requests to Dr. Ekberg at the Department of Nephrology and Transplantation, University Hospital, 205 03 Malmö, Sweden, or at henrik.ekberg@med.lu.se.
Investigators who participated in the Efficacy Limiting Toxicity Elimination (ELITE)–Symphony study are listed in the Appendix.
Appendix
Investigators who participated in the ELITE–Symphony study are as follows: Australia: R. Walker, F. Ierino, G. Russ, J. Eris, P. O'Connell; Austria: F. Mühlbacher, R. Margreiter; Belgium: Y. Vanrenterghem, P. Peeters, N. Lameire; Brazil: D. Carvalho, V. Garcia, R. Esmeraldo, H. Tedesco-Silva, L. Saber, G. Majella, G. Alves Filho, R. Gonçalves; Canada: S. Gourishankar, P. Daloze; Czech Republic: V. Treska, J. Dedochová, M. Kuman, P. Navrátil, S. Vítko; Germany: U. Frei, M. Büchler, M. Wiesel, L. Fricke, H.-H. Neumayer, E. Nagel, W. Arns, F. Pietruck, C. Hugo, M. Ketteler, V. Kliem, R. Viebahn, J. Klempnauer, B. Nashan, H. Wolters, C. Krieglstein, U. Ott; Greece: J. Boletis, D.N. Takoudas, A. Antoniadis; Israel: M. Shabtai, A. Yussim, S. Mizrahi, R. Ramadan, R. Nakache, E. Ahmed; Mexico: R. Reyes Acevedo, M. Barrón, R. Salinas-González; Poland: M. Durlik, M. Klinger; Spain: J.M. Grinyó, M. Arias, J.M. Morales, F. Oppenheimer, J. Sanchez-Plumed, I. Lampreave, F. Valdés, M. Ángel Gentil, G. Rodríguez, A. Osuna, D. Hernandez, M. Tabernero, F. Anaya, F. Ortega, M. Rivero Sánchez, R. Marcen, M. Gonzalez-Molina, R. Lauzurica; Sweden: H. Ekberg, L. Mjörnstedt; Turkey: A. Uğur Yalçın, E. Ok, E. Akoglu, A. Gürkan, A. Demirbaş, M. Şükrü Sever, M. Yenicesu, O. Oymak, U Erken, B. Erbay, K. Dilek, I. Titiz; United Kingdom: R. Chavez, M.L. Nicholson.
- References
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- Citing Articles (269)
Citing Articles
1
Markus Guba, Johann Pratschke, Christian Hugo, Bernhard K. Krämer, Andreas Pascher, Katharina Pressmar, Oliver Hakenberg, Michael Fischereder, Jens Brockmann, Joachim Andrassy, Bernhard Banas, Karl-Walter Jauch, . (2012) Early conversion to a sirolimus-based, calcineurin-inhibitor-free immunosuppression in the SMART trial: observational results at 24 and 36 months after transplantation. Transplant Internationalno-no
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K. Stylianou, I. Petrakis, V. Mavroeidi, S. Stratakis, G. Kokologiannakis, E. Lioudaki, C. Liotsi, N. Kroustalakis, E. Vardaki, S. Stratigis, K. Perakis, J. Kyriazis, L. Nakopoulou, E. Daphnis. (2012) Rapamycin induced ultrastructural and molecular alterations in glomerular podocytes in healthy mice. Nephrology Dialysis Transplantation
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Dustin Tedesco, Lukas Haragsim. (2012) Cyclosporine: A Review. Journal of Transplantation 2012, 1-7
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Gaetano Ciancio, Jeffrey J. Gaynor, Junichiro Sageshima, David Roth, Warren Kupin, Giselle Guerra, Lissett Tueros, Alberto Zarak, Lois Hanson, Susan Ganz, Linda Chen, Phillip Ruiz, Alan S. Livingstone, George W. Burke. (2012) Machine perfusion following static cold storage preservation in kidney transplantation: donor-matched pair analysis of the prognostic impact of longer pump time. Transplant International 25:1, 34-40
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F. Vincenti, C. P. Larsen, J. Alberu, B. Bresnahan, V. D. Garcia, J. Kothari, P. Lang, E. Mancilla Urrea, P. Massari, G. Mondragon-Ramirez, R. Reyes-Acevedo, K. Rice, L. Rostaing, S. Steinberg, J. Xing, M. Agarwal, M. B. Harler, B. Charpentier. (2012) Three-Year Outcomes from BENEFIT, a Randomized, Active-Controlled, Parallel-Group Study in Adult Kidney Transplant Recipients. American Journal of Transplantation 12:1, 210-217
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Raymond L. Heilman, Cherise Cortese, Xochiquetzal J. Geiger, Kerrie Younan, Hani M. Wadei, Martin L. Mai, Kunam S. Reddy, Thomas A. Gonwa. (2012) Impact of Early Conversion From Tacrolimus to Sirolimus on Chronic Allograft Changes in Kidney Recipients on Rapid Steroid Withdrawal. Transplantation 93:1, 47-53
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C. J. E. Watson, J. H. Dark. (2012) Organ transplantation: historical perspective and current practice. British Journal of Anaesthesia 108:suppl 1, i29-i42
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Ramin Vafadari, Willem Weimar, Carla C. Baan. (2012) Phosphospecific flow cytometry for pharmacodynamic drug monitoring: Analysis of the JAK-STAT signaling pathway. Clinica Chimica Acta
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Henri Vacher-Coponat, Valerie Moal, Monica Indreies, Raj Purgus, Anderson Loundou, Stephane Burtey, Philippe Brunet, Julie Moussi-Frances, Laurent Daniel, Bertrand Dussol, Yvon Berland. (2012) A Randomized Trial With Steroids and Antithymocyte Globulins Comparing Cyclosporine/Azathioprine Versus Tacrolimus/Mycophenolate Mofetil (CATM2) in Renal Transplantation. Transplantation1
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J. Al Wakeel, F.A.M. Shaheen, A. Al Alfi, E.H. Abbas Fagir, A. Iman, M.R.N. Nampoory, M.S.A. Al Mousawi, T. Said, H. Abou Zeinab, D.S. Shaker, B.B. Ghaedi. (2012) Cyclosporine Microemulsion Formulation (Sigmasporin Microral) Effect as First-Line Immunosuppressant on Renal Functions at 3 Years. Transplantation Proceedings 44:1, 94-100
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J. Uchida, N. Kuwabara, Y. Machida, T. Iwai, T. Naganuma, N. Kumada, T. Nakatani. (2012) Conversion of Stable Kidney Transplant Recipients From a Twice-Daily Prograf to a Once-Daily Tacrolimus Formulation: A Short-Term Study on its Effects on Glucose Metabolism. Transplantation Proceedings 44:1, 128-133
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L. S. Kean, S. Sen, O. Onabajo, K. Singh, J. Robertson, L. Stempora, A. C. Bonifacino, M. E. Metzger, D. E. L. Promislow, J. J. Mattapallil, R. E. Donahue. (2011) Significant mobilization of both conventional and regulatory T cells with AMD3100. Blood 118:25, 6580-6590
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Éric Thervet, Julien Zuber, Rebecca Sberro, Guillaume Canaud, Dany Anglicheau, Renaud Snanoudj, Marie-France Mamzer-Bruneel, Franck Martinez, Christophe Legendre. (2011) Traitements immunosuppresseurs : mécanismes d’action et utilisation clinique. Néphrologie & Thérapeutique 7:7, 566-581
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Christos Chatzikyrkou, Jan Menne, Wilfried Gwinner, Bernhard M. Schmidt, Frank Lehner, Cornelia Blume, Anke Schwarz, Hermann Haller, Mario Schiffer. (2011) Pathogenesis and management of hypertension after kidney transplantation. Journal of Hypertension 29:12, 2283-2294
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Gaetano Ciancio, Jeffrey J. Gaynor, Junichiro Sageshima, Giselle Guerra, Alberto Zarak, David Roth, Randolph Brown, Warren Kupin, Linda Chen, Lois Hanson, Lissett Tueros, Phillip Ruiz, Alan S. Livingstone, George W. Burke. (2011) Randomized Trial of Dual Antibody Induction Therapy With Steroid Avoidance in Renal Transplantation. Transplantation 92:12, 1348-1357
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Massimiliano Veroux, Tiziano Tallarita, Daniela Corona, Antonino D’Assoro, Carmelina Gurrieri, Pierfrancesco Veroux. (2011) Sirolimus in solid organ transplantation: current therapies and new frontiers. Immunotherapy 3:12, 1487-1497
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Robert S. Gaston. (2011) Our evolving understanding of late kidney allograft failure. Current Opinion in Organ Transplantation 16:6, 594-599
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Hafedh Marouani, Anastasios Zografidis, Athanassios Iliadis. (2011) Kinetic Nomograms Assist Individualization of Drug Regimens. Clinical Pharmacokinetics 50:12, 773-779
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Liset H. M. Pengel, Liang Q. Liu, Peter J. Morris. (2011) Do wound complications or lymphoceles occur more often in solid organ transplant recipients on mTOR inhibitors? A systematic review of randomized controlled trials. Transplant International 24:12, 1216-1230
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P. Braconnier, V. del Marmol, N. Broeders, M. Kianda, A. Massart, A. Lemy, L. Ghisdal, A. Le Moine, P. Madhoun, J. Racape, D. Abramowicz, K. M. Wissing. (2011) Combined introduction of anti-IL2 receptor antibodies, mycophenolic acid and tacrolimus: effect on malignancies after renal transplantation in a single-centre retrospective cohort study. Nephrology Dialysis Transplantation
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Adnan Sharif, Keshwar Baboolal. (2011) Complications associated with new-onset diabetes after kidney transplantation. Nature Reviews Nephrology 8:1, 34-42
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Vijay S. Gorantla, Gerald Brandacher, Stefan Schneeberger, Xin Xiao Zheng, Albert D. Donnenberg, Joseph E. Losee, W.P. Andrew Lee. (2011) Favoring the Risk–Benefit Balance for Upper Extremity Transplantation—The Pittsburgh Protocol. Hand Clinics 27:4, 511-520
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John R. Lake. (2011) Hot-topic debate on kidney function: Renal-sparing approaches are ineffective. Liver Transplantation 17:S3, S50-S53
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C. Ocampo, A. Aristizabal, J. Nieto, H. Abadia, W. Angel, C. Guzman, A. Mena, J. Vanegas, C. Velez, C. Aguirre, C. Yepes, G. Zuluaga. (2011) Induction Therapies in Kidney Transplantation: The Experience of Hospital Pablo Tobon Uribe, Medellín, Colombia 2005–2010. Transplantation Proceedings 43:9, 3359-3363
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Michael Jin Casey, Herwig-Ulf Meier-Kriesche. (2011) Calcineurin inhibitors in kidney transplantation. Current Opinion in Nephrology and Hypertension 20:6, 610-615
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C. J. Yates, S. Fourlanos, J. Hjelmesaeth, P. G. Colman, S. J. Cohney. (2011) New-Onset Diabetes After Kidney Transplantation-Changes and Challenges. American Journal of Transplantationno-no
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F. Cortazar, M. Z. Molnar, T. Isakova, M. E. Czira, C. P. Kovesdy, D. Roth, I. Mucsi, M. Wolf. (2011) Clinical Outcomes in Kidney Transplant Recipients Receiving Long-Term Therapy With Inhibitors of the Mammalian Target of Rapamycin. American Journal of Transplantationno-no
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HyeonSeok Hwang, Jung Yeon Ghee, Ji Hyun Song, ShangGuo Piao, Chul Woo Yang. (2011) Comparison of adverse drug reaction profiles of two tacrolimus formulations in rats. Immunopharmacology and Immunotoxicology1-9
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Alan G Jardine, Robert S Gaston, Bengt C Fellstrom, Hallvard Holdaas. (2011) Prevention of cardiovascular disease in adult recipients of kidney transplants. The Lancet 378:9800, 1419-1427
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Raymond L. Heilman, Kerrie Younan, Hani M. Wadei, Martin L. Mai, Kunam S. Reddy, Harini A. Chakkera, Thomas A. Gonwa. (2011) Results of a Prospective Randomized Trial of Sirolimus Conversion in Kidney Transplant Recipients on Early Corticosteroid Withdrawal. Transplantation 92:7, 767-773
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Kakit Chan, David Taube, Candice Roufosse, Terence Cook, Paul Brookes, Dawn Goodall, Jack Galliford, Tom Cairns, Anthony Dorling, Neill Duncan, Nadey Hakim, Andrew Palmer, Vassilios Papalois, Anthony N. Warrens, Michelle Willicombe, Adam G. McLean. (2011) Kidney Transplantation With Minimized Maintenance: Alemtuzumab Induction With Tacrolimus Monotherapy—An Open Label, Randomized Trial. Transplantation 92:7, 774-780
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Brian J Nankivell, Dirk RJ Kuypers. (2011) Diagnosis and prevention of chronic kidney allograft loss. The Lancet 378:9800, 1428-1437
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Maarten Naesens. (2011) Switching From Calcineurin Inhibitors to Mammalian Target of Rapamycin Inhibitors—Finally Caught the Right Wave?. Transplantation 92:7, 728-730
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A. Barney Hawthorne. 2011. Which Calcineurin Inhibitor and When?. , 102-105.
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T.R. Türk, O. Witzke. (2011) Diabetes nach Nierentransplantation. Der Nephrologe 6:5, 428-434
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Barry Kahan. (2011) Toxicity spectrum of inhibitors of mammalian target of rapamycin in organ transplantation: etiology, pathogenesis and treatment. Expert Opinion on Drug Safety 10:5, 727-749
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Lars Pape, Frank Lehner, Cornelia Blume, Thurid Ahlenstiel. (2011) Pediatric Kidney Transplantation Followed by De Novo Therapy With Everolimus, Low-Dose Cyclosporine A, and Steroid Elimination: 3-Year Data. Transplantation 92:6, 658-662
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Sarah E. Yost, Rochelle Byrne, Bruce Kaplan. (2011) Transplantation: mTOR inhibition in kidney transplant recipients. Nature Reviews Nephrology 7:10, 553-555
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Ben Sprangers, Dirk R. Kuypers, Yves Vanrenterghem. (2011) Immunosuppression: Does One Regimen Fit All?. Transplantation 92:3, 251-261
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Kamisha L Johnson-Davis, Soumo De, Ernest Jimenez, Gwendolyn A McMillin, Barun K De. (2011) Evaluation of the Abbott ARCHITECT i2000 Sirolimus Assay and Comparison With the Abbott IMx Sirolimus Assay and an Established Liquid Chromatography–Tandem Mass Spectrometry Method. Therapeutic Drug Monitoring 33:4, 453-459
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K. Budde. (2011) How to Use mTOR Inhibitors? The Search Goes On. American Journal of Transplantation 11:8, 1551-1552
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Josep M. Campistol, Johan W. de Fijter, Björn Nashan, Hallvard Holdaas, Štefan Vítko, Christophe Legendre. (2011) Everolimus and Long-Term Outcomes in Renal Transplantation. Transplantation 92:Supplement, S3-S26
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R Byrne, S E Yost, B Kaplan. (2011) Mycophenolate Mofetil Monitoring: Is There Evidence That It Can Improve Outcomes?. Clinical Pharmacology & Therapeutics 90:2, 204-206
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S. M. Flechner, M. Glyda, S. Cockfield, J. Grinyó, Ch. Legendre, G. Russ, S. Steinberg, K. M. Wissing, S. S. Tai. (2011) The ORION Study: Comparison of Two Sirolimus-Based Regimens versus Tacrolimus and Mycophenolate Mofetil in Renal Allograft Recipients. American Journal of Transplantation 11:8, 1633-1644
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Liang Li, Chuan-Jiang Li, Lei Zheng, Yan-Jun Zhang, Hai-Xia Jiang, Bo Si-Tu, Zhong-Hai Li. (2011) Tacrolimus dosing in Chinese renal transplant recipients: a population-based pharmacogenetics study. European Journal of Clinical Pharmacology 67:8, 787-795
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K. Heldal, A. Hartmann, T. Leivestad, A. Foss, K. Midtvedt. (2011) Risk variables associated with the outcome of kidney recipients >70 years of age in the new millennium. Nephrology Dialysis Transplantation 26:8, 2706-2711
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Bobby Chacko. (2011) Clinical application of mTORi based immunosuppression for renal transplantation in India. Clinical Transplantationno-no
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J. Pascual, A. Royuela, C. Galeano, M. Crespo, J. Zamora. (2011) Very early steroid withdrawal or complete avoidance for kidney transplant recipients: a systematic review. Nephrology Dialysis Transplantation
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Elaine C. Jolly, Christopher J.E. Watson. (2011) Modern immunosuppression. Surgery (Oxford) 29:7, 312-318
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Hideyuki Watanabe, Nobuhisa Hirase, Hideaki Goda, Hiroshi Nishikawa, Shoichiro Ikuyama. (2011) Oral low-dose tacrolimus therapy for refractory hemophagocytic syndrome associated with systemic lupus erythematosus. Modern Rheumatology
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Felix Seibert, Carolin Behrendt, Sven Schmidt, Markus van der Giet, Walter Zidek, Timm H. Westhoff. (2011) Differential effects of cyclosporine and tacrolimus on arterial function. Transplant International 24:7, 708-715
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S. Friman, W. Arns, B. Nashan, F. Vincenti, B. Banas, K. Budde, D. Cibrik, L. Chan, J. Klempnauer, S. Mulgaonkar, M. Nicholson, J. Wahlberg, K.-M. Wissing, K. Abrams, S. Witte, E. S. Woodle. (2011) Sotrastaurin, a Novel Small Molecule Inhibiting Protein-Kinase C: Randomized Phase II Study in Renal Transplant Recipients. American Journal of Transplantation 11:7, 1444-1455
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Henrik Ekberg, Teun van Gelder, Bruce Kaplan, Corrado Bernasconi. (2011) Relationship of Tacrolimus Exposure and Mycophenolate Mofetil Dose With Renal Function After Renal Transplantation. Transplantation 92:1, 82-87
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H. Tedesco Silva Jr., C. R. Felipe, M. Abbud-Filho, V. Garcia, J. O. Medina-Pestana. (2011) The Emerging Role of Brazil in Clinical Trial Conduct for Transplantation. American Journal of Transplantation 11:7, 1368-1375
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C. Ponticelli. (2011) Present and Future of Immunosuppressive Therapy in Kidney Transplantation. Transplantation Proceedings 43:6, 2439-2440
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U. Erdbruegger, I. Scheffner, M. Mengel, A. Schwarz, W. Verhagen, H. Haller, W. Gwinner. (2011) Impact of CMV infection on acute rejection and long-term renal allograft function: a systematic analysis in patients with protocol biopsies and indicated biopsies. Nephrology Dialysis Transplantation
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Rolf Weimer, Sabine Deisz, Hartmut Dietrich, Fabrice Renner, Rolf-Hasso Bödeker, Volker Daniel, Shirin Kamali-Ernst, Wolfgang Ernst, Winfried Padberg, Gerhard Opelz. (2011) Impact of maintenance immunosuppressive regimens - balance between graft protective suppression of immune functions and a near physiological immune response. Transplant International 24:6, 596-609
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Marcia Kho, Karlien Cransberg, Willem Weimar, Teun van Gelder. (2011) Current immunosuppressive treatment after kidney transplantation. Expert Opinion on Pharmacotherapy 12:8, 1217-1231
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Z. Kaposztas, E. Gyurus, B.D. Kahan. (2011) New-Onset Diabetes After Renal Transplantation: Diagnosis, Incidence, Risk Factors, Impact on Outcomes, and Novel Implications. Transplantation Proceedings 43:5, 1375-1394
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Gaetano Ciancio, Jeffrey J. Gaynor, Alberto Zarak, Junichiro Sageshima, Giselle Guerra, David Roth, Randolph Brown, Warren Kupin, Linda Chen, Lissett Tueros, Lois Hanson, Phillip Ruiz, George W. Burke. (2011) Randomized Trial of Mycophenolate Mofetil Versus Enteric-Coated Mycophenolate Sodium in Primary Renal Transplantation With Tacrolimus and Steroid Avoidance: Four-Year Analysis. Transplantation 91:11, 1198-1205
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R. Lorho, J. Hardwigsen, J. Dumortier, G.-P. Pageaux, F. Durand, T. Bizollon, A.-S. Blanc, F. Di Giambattista, C. Duvoux. (2011) Regression of new-onset diabetes mellitus after conversion from tacrolimus to cyclosporine in liver transplant patients: Results of a pilot study. Clinics and Research in Hepatology and Gastroenterology 35:6-7, 482-488
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Leonard C. Hymes, Barry L. Warshaw. (2011) Five-year experience using sirolimus-based, calcineurin inhibitor-free immunosuppression in pediatric renal transplantation. Pediatric Transplantation 15:4, 437-441
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Roberto Marcén. (2011) Immunosuppression and renal transplant rejection: review of current and emerging therapies. Clinical Investigation 1:6, 859-877
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Robert S. Woodward, Marc C. Flore, Gerardo Machnicki, Daniel C. Brennan. (2011) The Long-Term Outcomes and Costs of Diabetes Mellitus among Renal Transplant Recipients: Tacrolimus versus Cyclosporine. Value in Health 14:4, 443-449
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K. Claes, H.-U. Meier-Kriesche, J. D. Schold, Y. Vanrenterghem, P. F. Halloran, H. Ekberg. (2011) Effect of different immunosuppressive regimens on the evolution of distinct metabolic parameters: evidence from the Symphony study. Nephrology Dialysis Transplantation
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David Berglund, Mats Bengtsson, Alireza Biglarnia, Erik Berglund, Shinji Yamamoto, Bengt von Zur-Mühlen, Tomas Lorant, Gunnar Tufveson. (2011) Screening of mortality in transplant patients using an assay for immune function. Transplant Immunology 24:4, 246-250
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Herwig-Ulf Meier-Kriesche, Pierre Merville, Helio Tedesco-Silva, Uwe Heemann, Petar Kes, Hermann Haller, Lionel Rostaing, Nesrin Gafner, Corrado Bernasconi. (2011) Mycophenolate Mofetil Initiation in Renal Transplant Patients at Different Times Posttransplantation: The TranCept Switch Study. Transplantation 91:9, 984-990
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Igor Tsaur, Martin Gasser, Beatriz Aviles, Jens Lutz, Lydia Lutz, Martin Grimm, Volkmar Lange, Kai Lopau, Uwe Heemann, Christoph-Thomas Germer, Anil Chandraker, Ana Maria Waaga-Gasser. (2011) Donor antigen-specific regulatory T-cell function affects outcome in kidney transplant recipients. Kidney International 79:9, 1005-1012
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Allison Webber, Ryutaro Hirose, Flavio Vincenti. (2011) Novel Strategies in Immunosuppression: Issues in Perspective. Transplantation 91:10, 1057-1064
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Matthew R Weir, Shamkant Mulgaonkar, Laurence Chan, Hamid Shidban, Thomas H Waid, Dennis Preston, Roberto N Kalil, Thomas C Pearson. (2011) Mycophenolate mofetil-based immunosuppression with sirolimus in renal transplantation: a randomized, controlled Spare-the-Nephron trial. Kidney International 79:8, 897-907
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Arthur J. Matas. (2011) Chronic Progressive Calcineurin Nephrotoxicity: An Overstated Concept. American Journal of Transplantation 11:4, 687-692
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Stuart M Flechner. (2011) Can the nephron be spared?. Kidney International 79:8, 804-806
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Spencer T Martin, Eric M Tichy, Steven Gabardi. (2011) Belatacept: A Novel Biologic for Maintenance Immunosuppression After Renal Transplantation. Pharmacotherapy 31:4, 394-407
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Kumi Hirano, Shuji Maruyama, Yasuaki Mino, Takafumi Naito, Junichi Kawakami. (2011) Suitability of chemiluminescent enzyme immunoassay for the measurement of blood tacrolimus concentrations in rheumatoid arthritis. Clinical Biochemistry 44:5-6, 397-402
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C.C. Geddes, R. Gunson, E. Mazonakis, R. Wan, L. Thomson, M. Clancy, W.F. Carman. (2011) BK viremia surveillance after kidney transplant: single-center experience during a change from cyclosporine-to lower-dose tacrolimus-based primary immunosuppression regimen. Transplant Infectious Disease 13:2, 109-116
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B. Hocker, T. van Gelder, J. Martin-Govantes, P. Machado, H. Tedesco, J. Rubik, M. Dehennault, C. Garcia Meseguer, B. Tonshoff, . (2011) Comparison of MMF efficacy and safety in paediatric vs. adult renal transplantation: subgroup analysis of the randomised, multicentre FDCC trial. Nephrology Dialysis Transplantation 26:3, 1073-1079
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L.V. Schewior. (2011) Belatacept nach Nierentransplantation unter Vermeidung von Steroiden. Der Nephrologe 6:2, 159-161
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Klemens Budde, Thomas Becker, Wolfgang Arns, Claudia Sommerer, Petra Reinke, Ute Eisenberger, Stefan Kramer, Wolfgang Fischer, Harald Gschaidmeier, Frank Pietruck. (2011) Everolimus-based, calcineurin-inhibitor-free regimen in recipients of de-novo kidney transplants: an open-label, randomised, controlled trial. The Lancet 377:9768, 837-847
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K. Midtvedt, H. Holdaas. (2011) Belatacept: BENEFIT to the kidney?. American Journal of Transplantation 11:3, 633-633
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I. Helal, L. Chan. (2011) Steroid and Calcineurin Inhibitor—Sparing Protocols in Kidney Transplantation. Transplantation Proceedings 43:2, 472-477
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Janna Huskey, Alexander C. Wiseman. (2011) Chronic viral hepatitis in kidney transplantation. Nature Reviews Nephrology 7:3, 156-165
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Flavio Vincenti. (2011) Yes There Is Benefit to BENEFIT. American Journal of Transplantation 11:3, 634-634
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Claudia Sommerer, Petra Glander, Wolfgang Arns, Tofan Ariatabar, Stefan Kramer, Eva-Maria Vogel, Maria Shipkova, Wolfgang Fischer, Lutz Liefeldt, Ruth Hackenberg, Jan Schmidt, Martin Zeier, Klemens Budde. (2011) Safety and Efficacy of Intensified Versus Standard Dosing Regimens of Enteric-Coated Mycophenolate Sodium in De Novo Renal Transplant Patients. Transplantation1
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Sofia Sofroniadou, David Goldsmith. (2011) Mammalian Target of Rapamycin (mTOR) Inhibitors. Drug Safety 34:2, 97-115
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Britta Höcker, Burkhard Tönshoff. (2011) Calcineurin Inhibitor-Free Immunosuppression in Pediatric Renal Transplantation. Pediatric Drugs 13:1, 49-69
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Martin Zeier, Markus Van Der Giet. (2011) Calcineurin inhibitor sparing regimens using m-target of rapamycin inhibitors: an opportunity to improve cardiovascular risk following kidney transplantation?. Transplant International 24:1, 30-42
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R. Ferguson, J. Grinyó, F. Vincenti, D. B. Kaufman, E. S. Woodle, B. A. Marder, F. Citterio, W. H. Marks, M. Agarwal, D. Wu, Y. Dong, P. Garg. (2011) Immunosuppression with Belatacept-Based, Corticosteroid-Avoiding Regimens in De Novo Kidney Transplant Recipients. American Journal of Transplantation 11:1, 66-76
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F. Branco, V. Cavadas, L. Osório, F. Carvalho, L. Martins, L. Dias, A. Castro-Henriques, E. Lima. (2011) The Incidence of Cancer and Potential Role of Sirolimus Immunosuppression Conversion on Mortality Among a Single-Center Renal Transplantation Cohort of 1,816 Patients. Transplantation Proceedings 43:1, 137-141
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R. L. Heilman, S. Nijim, H. A. Chakkera, Y. Devarapalli, A. A. Moss, D. C. Mulligan, M. J. Mazur, K. Hamawi, J. W. Williams, K. S. Reddy. (2011) Impact of Acute Rejection on Kidney Allograft Outcomes in Recipients on Rapid Steroid Withdrawal. Journal of Transplantation 2011, 1-8
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Yoshiko Miura, Shigeru Satoh, Mitsuru Saito, Kazuyuki Numakura, Takamitsu Inoue, Takashi Obara, Hiroshi Tsuruta, Shintaro Narita, Yohei Horikawa, Norihiko Tsuchiya, Atsushi Komatsuda, Hideaki Kagaya, Masatomo Miura, Tomonori Habuchi. (2011) Factors Increasing Quantitative Interstitial Fibrosis From 0 hr to 1 Year in Living Kidney Transplant Patients Receiving Tacrolimus. Transplantation 91:1, 78-85
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Samir J. Patel, Kyle L. Dawson, Richard J. Knight, Abdul Abdellatif, Katafan Achkar, Lillian W. Gaber, A. Osama Gaber. (2011) The role of mTOR inhibition in renal transplant immune suppression. Dialysis & Transplantation 40:1, 23-29
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R. Baker, A. Jardine, Peter Andrews. (2011) Renal Association Clinical Practice Guideline on Post-operative Care of the Kidney Transplant Recipient. Nephron Clinical Practice 118:s1, c311-c347
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Christophe Bazin, Amélie Guinedor, Caroline Barau, Claire Gozalo, Philippe Grimbert, Christophe Duvoux, Valérie Furlan, Laurent Massias, Anne Hulin. (2010) Evaluation of the Architect® tacrolimus assay in kidney, liver, and heart transplant recipients. Journal of Pharmaceutical and Biomedical Analysis 53:4, 997-1002
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