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

Renal Allograft Recipients Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Renal Allograft Recipients

Clinical Trial Details

NCT number	NCT00470665
Study type	Interventional
Source	Wyeth is now a wholly owned subsidiary of Pfizer
Contact
Status	Completed
Phase	Phase 3
Start date	August 2002
Completion date	July 2004

View Details

See also
	Status	Clinical Trial	Phase
	Completed	`NCT00895583` - Study Evaluating A Planned Transition From Tacrolimus To Sirolimus In Kidney Transplant Recipients	Phase 4
	Recruiting	`NCT04877288` - A Study to Evaluate the Benefits and Risks of Conversion of Existing Adolescent Kidney Transplant Recipients Aged 12 to <18 Years to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications	Phase 3