Study Evaluating of Calcineurin Inhibitors Versus Sirolimus in Renal Allograft Recipient

• Status: Terminated
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate whether conversion from cyclosporine, a calcineurin inhibitor (CI) to sirolimus (SRL) results in improved long-term renal function without a negative impact on safety or immunosuppressive efficacy, and to further examine the potential of SRL to reduce the severity and/or progression of chronic allograft nephropathy (CAN).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Calcineurin Inhibitors; Cyclosporine; Cyclosporins; Everolimus; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

• Subjects must be at least 18 years of age.

• Subjects who are 6 to 60 months after renal transplantation.

• Subjects who have a stable graft function.

Exclusion Criteria:

• Subjects with active major infection, including HIV, decreased platelets, elevated lipids, or multiple organ transplants.