NCT00428064

Study Evaluating Sirolimus and Cyclosporine in Kidney Transplant Recipients

A Randomized, Open-Label Study of Continuous Therapy With Cyclosporine and Sirolimus Versus Induction With Cyclosporine and Sirolimus Followed by Continuous Therapy With Sirolimus in Renal Allograft Recipients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 408 (planned)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

Summary

To assess equivalence in the rates of functional graft survival at 12 months after transplantation in patients receiving continuous therapy with cyclosporine (CsA, Sandimmune, Neoral) and sirolimus versus induction with CsA and sirolimus followed by CsA elimination and concentration-controlled sirolimus.

Conditions

• Renal Transplantation

Interventions

Type	Name	Description
DRUG	Sirolimus
DRUG	cyclosporine

Timeline

• Start date: 1998-05-01
• Completion: 2004-06-01
• First posted: 2007-01-29
• Last updated: 2007-01-29