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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Heart transplantation (> 6 months post-operation)

• Renal failure (serum creatinine stably > 1.7 mg/dl

• Cyclosporine trough blood level < 110 ng/ml

Exclusion Criteria:

• < 18 years of age

• Rapamycin intolerability

• Active infection

• Pregnancy, breast feeding

• Major elective surgery planned in study period

• Thrombopenia < 100,000/ml