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Journal of Transplantation
Volume 2010, Article ID 731426, 10 pages
http://dx.doi.org/10.1155/2010/731426
Clinical Study

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

1Department of Internal Medicine, Erasmus MC, ’s-Gravendijksewal 230, 3015 CE Rotterdam, The Netherlands
2Nephrology Service, Hospital Clinico de Valladolid, 47011 Valladolid, Spain
3Nephrology Service, Hospital General de Alicante, 03070 Alicante, Spain
4Nephrology Service, Hospital de Rangueil, Toulouse, France
5Department of General, Vascular, and Transplantation Surgery, Medizinische Hochschule Hannover, Hannover, Germany
6Nephrology and Renal Transplant Service, Hospital Tenon, Paris, France
7Unit of Anesthesiology and Intensive Care, Wojewódzki Szpital Zespolony, Szczecin, Poland
8Department of Internal Diseases and Nephrology, Centralny Szpital Kliniczny MSWiA, Warszawa, Poland
9Nephrology Service, Hospital Son Dureta, Palma de Mallorca, Spain
10Transplant Center, FN a LF UP Olomouc, Olomouc, Czech Republic
11Transplant Center, FNsP Ostrava, Ostrava, Czech Republic
12Urology Clinic, University Hospital Rostock, Rostock, Germany
13Servicio de Nefrologia, Hospital Universitario Dr. Peset, Valencia, Spain
14Nephrology Service, Hospital la Cavale Blance, Brest, France
15Department of Nephrology, Medical University of Gdansk, Gdansk, Poland
16Transplantation Unit, Wojewódzki Szpital Zespolony, Poznan, Poland

Received 22 February 2010; Revised 9 June 2010; Accepted 30 July 2010

Academic Editor: Bruce Kaplan

Copyright © 2010 Eveline Van Gurp et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

In a multicenter trial, renal transplant recipients were randomized to tacrolimus with fixed-dose sirolimus (Tac/SRL, = 318) or tacrolimus with MMF (Tac/MMF, = 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 ( ) while CMV, leukopenia, and diarrhea incidences were higher with Tac/MMF ( ). The incidence of any antidiabetic treatment for 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.