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. 2010:2010:731426.
doi: 10.1155/2010/731426. Epub 2010 Oct 5.

Comparable Renal Function at 6 Months with Tacrolimus Combined with Fixed-Dose Sirolimus or MMF: Results of a Randomized Multicenter Trial in Renal Transplantation

Eveline Van Gurp  1 , Jesus Bustamante, Antonio Franco, Lionel Rostaing, Thomas Becker, Eric Rondeau, Zenon Czajkowski, Andrzej Rydzewski, Antonio Alarcon, Petr Bachleda, Jiri Samlik, Dirk Burmeister, Luis Pallardo, Marie-Christine Moal, Boleslaw Rutkowski, Zbigniew Wlodarczyk
Affiliations

Comparable Renal Function at 6 Months with Tacrolimus Combined with Fixed-Dose Sirolimus or MMF: Results of a Randomized Multicenter Trial in Renal Transplantation

Eveline Van Gurp et al. J Transplant. 2010.

Abstract

In a multicenter trial, renal transplant recipients were randomized to tacrolimus with fixed-dose sirolimus (Tac/SRL, N = 318) or tacrolimus with MMF (Tac/MMF, N = 316). Targeted tacrolimus trough levels were lower in the Tac/SRL group after day 14. The primary endpoint was renal function at 6 months using creatinine clearance (Cockcroft-Gault) and was comparable at 66.4 mL/min (SE 1.4) with Tac/SRL and at 65.2mL/min (SE 1.3) with Tac/MMF (completers). Biopsy-confirmed acute rejection was 15.1% (Tac/SRL) and 12.3% (Tac/MMF). In both groups, graft survival was 93% and patient survival was 99.0%. Premature withdrawal due to an adverse event was twice as high in the Tac/SRL group, 15.1% versus 6.3%. Hypercholesterolemia incidence was higher with Tac/SRL (P < .05) while CMV, leukopenia, and diarrhea incidences were higher with Tac/MMF (P < .05). The incidence of any antidiabetic treatment for >30 consecutive days in previously nondiabetic patients was 17.8%, Tac/SRL, and 24.8%, Tac/MMF. Evaluation at 6 months showed comparable renal function using tacrolimus/sirolimus and tacrolimus/MMF regimens.

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Figures

Figure 1
Figure 1
The full analysis set, which consisted of all patients who received at least one dose of study drug, included 318 patients in the Tac/SRL group and 316 patients in the Tac/MMF group. More patients in the Tac/SRL group withdrew from the study prematurely, the majority because of an adverse event.
Figure 2
Figure 2
Data presented are for the FAS population. Mean tacrolimus trough levels in the Tac/SRL group were higher than the recommended upper level throughout the study. In the Tac/MMF group, mean trough levels were within the recommended ranges from month 3 onward.
Figure 3
Figure 3
Estimated rate of patients free from biopsy-confirmed acute rejection (Kaplan-Meier method). The estimated rate of patients free from BCAR (Kaplan-Meier method) at 6 months was 83.8% in the Tac/SRL group and 87.1% in the Tac/MMF group (difference between groups −3.0%; 95% confidence interval: −8.9% to 2.4% [Greenwood formula]).
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