Study Of The Safety And Efficacy Of Conversion From A CNI To Sirolimus In Renally-Impaired Heart Transplant Recipients

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to determine whether converting from calcineurin inhibitor (CNI) therapy to sirolimus therapy will be more effective than continuing calcineurin inhibitor therapy with respect to renal function in cardiac transplant recipients with mild to moderate renal dysfunction.

• 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:

• Cardiac transplant recipients age 18 years or older receiving cyclosporine or tacrolimus since the time of transplant.

• 12 months after cardiac transplantation but less than 96 months post-transplantation.

Exclusion Criteria:

• Multiple-organ transplant recipients (such as heart-lung, heart-kidney, or heart after kidney transplant recipients).

• Prior or current use of sirolimus or everolimus unless administration was part of a "CNI holiday" lasting no more than 10 days.

• History of acute rejection within the last 3 months, malignancy within the last 5 years (except for adequately treated basal cell or squamous cell carcinoma of the skin), and human immunodeficiency virus (HIV) patients.