Clinical Trials Directory

Trials / Completed

CompletedNCT00470665

Study Comparing Sirolimus/Prograf vs Sirolimus/CsA in High-Risk Renal Transplant Recipients

An Open-Label, Concentration-Controlled, Randomized, 12-Month Study of Prograf + Rapamune + Corticosteroids Compared to Cyclosporine,USP (Modified) + Rapamune + Corticosteroids in High Risk Renal Allograft Recipients

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

Summary

The purpose of this study is to assess whether in high-risk kidney transplant patients (patients whose previous kidney transplant failed, have a high PRA lab test result or are of African-American descent) that a combination of Rapamune with Prograf and steroids will prevent acute rejection as well as Rapamune and cyclosporine and steroids.

Conditions

Interventions

TypeNameDescription
DRUGRapamune

Timeline

Start date
2002-08-01
Completion
2004-07-01
First posted
2007-05-08
Last updated
2007-05-08

Source: ClinicalTrials.gov record NCT00470665. Inclusion in this directory is not an endorsement.