drugset
drugset / Trial / NCT00478608

Study Evaluating Rapamune® Maintenance Regimen

NCT00478608 ↗

Phase 3 Completed 79 enrolled Wyeth is now a wholly owned subsidiary of Pfizer
Non-randomizedSingle-groupOpen-labelPrevention

Summary

Primary : To evaluate the efficacy of sirolimus assessed by the incidence of biopsy-confirmed acute rejection episode at 6 months after transplantation in Korean renal transplantation recipients. Secondary : 1. To evaluate the safety of sirolimus over 12 months after transplantation in Korean renal transplantation recipients. 2. To evaluate graft function, patient survival and graft survival at 6 and 12 months after transplantation, and to investigate the incidence of biopsy-confirmed acute rejection episode at 12 months after transplantation.

Timeline

Start
2007-03
Primary completion
2008-11
Completion
2008-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Sirolimus Small molecule 2 mg —

Indications

No indication recorded.