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

Phase 4

Completed

• Conditions: Heart Transplantation; Renal Failure

• Registration Number: NCT00123331
• Lead Sponsor: Heidelberg University

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2003-10
• Study Completion: 2005-04
• Status Verified: 2005-06
• Study First Submitted: 2005-07-18
• Study First Submitted QC: 2005-07-19
• Study First Posted: 2005-07-22
• Last Update Submitted: 2005-08-01
• Last Update Posted: 2005-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Renal function after 6 months (serum creatinine, calculated creatinine clearance)

Secondary Outcome Measures

Name	Time	Method
Survival
Rejection (clinical)
Tolerability
Blood pressure

Trial Locations

Locations (1)

Medizinische Universitätsklinik, Kardiologie; 🇩🇪 Heidelberg, Germany