Overview

Rapamycin Use in Calcineurin Inhibitor (CNI)-Free Immunosuppression for Stabilization/Improvement of Renal Function After Heart Transplantation

Status:
Completed

Trial end date:
2005-04-01

Target enrollment:

Participant gender:

Summary

Clinical Problem: Renal insufficiency after heart transplantation caused by cyclosporine medication was addressed. Current therapeutic approaches include cyclosporine reduction or discontinuation. It is unclear whether discontinuation of low dose cyclosporine also has a beneficial effect, i.e. is there a threshold effect for cyclosporine nephrotoxicity? Study Design: Heart transplant patients with a moderate degree of renal failure on low dose cyclosporine were randomized to either a) no change; or b) discontinuation of cyclosporine and initiation of rapamycin immunosuppression. Read-Out: Renal function after 6 months; tolerability; and safety were assessed.

Phase:

Phase 4

Details

Lead Sponsor:

Heidelberg University

Collaborator:

Wyeth is now a wholly owned subsidiary of Pfizer

Treatments:

Calcineurin Inhibitors
Cyclosporine
Cyclosporins
Everolimus
Sirolimus