Comparable Renal Function at 6 Months with Tacrolimus Combined with Fixed-Dose Sirolimus or MMF: Results of a Randomized Multicenter Trial in Renal Transplantation.
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.
Department of Internal Medicine, Erasmus MC, 's-Gravendijksewal 230, 3015 CE Rotterdam, The Netherlands.
Eveline
E
Van Gurp
Jesus
J
Bustamante
Antonio
A
Franco
Lionel
L
Rostaing
Thomas
T
Becker
Eric
E
Rondeau
Zenon
Z
Czajkowski
Andrzej
A
Rydzewski
Antonio
A
Alarcon
Petr
P
Bachleda
Jiri
J
Samlik
Dirk
D
Burmeister
Luis
L
Pallardo
Marie-Christine
MC
Moal
Boleslaw
B
Rutkowski
Zbigniew
Z
Wlodarczyk