Renal Transplantation Clinical Trial
Official title:
An Open-Label, Non-Randomized Study To Evaluate The Steady-State Pharmacokinetics Of Sirolimus Tablets In Chinese Patients With Stable Renal Allografts
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
n/a
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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