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

Abstract EN

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.