NCT00478608

Study Evaluating Rapamune® Maintenance Regimen

A Clinical Study to Evaluate the Efficacy and Safety of Cyclosporine (CsA) and Sirolimus (SRL) Induction Followed by Cyclosporine Withdrawal in Korean Renal Allograft Recipients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Transplant

Interventions

Type	Name	Description
DRUG	Sirolimus (Rapamune®)	(1mg tablets): Initial loading dose of 6mg/day, followed by maintenance dose of 2mg/day, which was adjusted to specified trough level.

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2007-05-25
• Last updated: 2010-04-28
• Results posted: 2010-01-07

Locations

9 sites across 1 country: South Korea