A Randomized, Open-Label, Comparative Evaluation of the Safety and Efficacy of Sirolimus Versus Cyclosporine When Combined in a Regimen Containing Basiliximab, Mycophenolate Mofetil, and Corticosteroids in Primary De Novo Renal Allograft Recipients

Wyeth is now a wholly owned subsidiary of Pfizer0 sites500 target enrollmentJune 2005

ConditionsKidney Transplant

Drugssirolimus

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Kidney Transplant
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Enrollment: 500
Primary Endpoint: To demonstrate the superiority of the sirolimus regimen versus cyclosporin A by intent to treat analysis of kidney function at 52 weeks, measured by mean glomerular filtration rate (GFR)
Status: Terminated
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to determine if one drug is superior to another with regard to safety and the preservation of renal function after a kidney transplant.

Registry

clinicaltrials.gov

Start Date

June 2005

End Date

August 2006

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Dialysis patients who will be receiving their first kidney transplant
•Weight over 88 pounds (lbs.)

Exclusion Criteria

•Very high cholesterol levels
•Organ donor over 65 years of age if living; over 60 years of age if cadaveric.

Outcomes

Primary Outcomes

To demonstrate the superiority of the sirolimus regimen versus cyclosporin A by intent to treat analysis of kidney function at 52 weeks, measured by mean glomerular filtration rate (GFR)

Non-inferiority of the composite of graft loss and death at 52 weeks

Secondary Outcomes

Incidence and severity of rejection at 12, 24, 52, 104, 156, 208 weeks; GFR at 24, 104, 156, 208 weeks; progression of chronic allograft nephropathy or deterioration of transplanted kidney at 52 weeks
quality of life at 24, 52 and 104 weeks