CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 79 enrolled
Drug / intervention
Sirolimus (Rapamune®)drug
Likely dose
Sirolimus (Rapamune®) 1mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00478608
NCT00478608Phase 3Completed
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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

Wyeth is now a wholly owned subsidiary of Pfizer·interventional·Posted May 25, 2007·Updated Apr 28, 2010

In Brief

A Phase 3 clinical trial evaluating Sirolimus (Rapamune®) for Renal Transplant. Completed, enrolled 79 participants across 9 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Transplant
CountriesSouth Korea
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 25, 2007
Enrollment StartMar 1, 2007
Primary CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 19.1 years ago

Interventions

Sirolimus (Rapamune®)drug

(1mg tablets): Initial loading dose of 6mg/day, followed by maintenance dose of 2mg/day, which was adjusted to specified trough level.