Open-Label, Randomized Study of Transition From Tacrolimus to Sirolimus Immunosuppression in Renal Allograft Recipients.

ABSTRACT:

Unlabelled

Calcineurin inhibitor-associated nephrotoxicity and other adverse events have prompted efforts to minimize/eliminate calcineurin inhibitor use in kidney transplant recipients.

Methods

This open-label, randomized, multinational study evaluated the effect of planned transition from tacrolimus to sirolimus on kidney function in renal allograft recipients. Patients received tacrolimus-based immunosuppression and then were randomized 3 to 5 months posttransplantation to transition to sirolimus or continue tacrolimus. The primary end point was percentage of patients with 5 mL/min per 1.73 m(2) or greater improvement in estimated glomerular filtration rate from randomization to month 24.

Results

The on-therapy population included 195 patients (sirolimus, 86; tacro

SUBMITTER: Tedesco-Silva H 

PROVIDER: S-EPMC4946511 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature