Study To Evaluate Pharmacokinetics Of Sirolimus In Stable Renal Transplant Recipients
Status:
Completed
Trial end date:
2011-04-01
Target enrollment:
Participant gender:
Summary
Sirolimus, 1 mg, white, triangular tablets (Rapamune®) was approved on 03 April 2007 in China
for prophylaxis of organ rejection in renal transplantation. A pharmacokinetic (PK) study to
be conducted in renal allograft recipients was requested by State Food and Drug
Administration (SFDA) to provide further guidance for clinical use.
To minimize risk to patients, this study is designed to collect blood PK samples from renal
allograft recipients who are currently under sirolimus (1 mg tablets) treatment with or
without concomitant medication(s). PK samples will be collected from these patients to
characterize the steady state PK of sirolimus during sirolimus maintenance therapy. This
study will not involve any changes to the established treatment regimen for the patients who
enroll in the study