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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Rapamycin Use in CNI-Free Immunosuppression for Stabilization/Improvement of Renal Function After Heart Transplantation

Conditions
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Heart Transplantation, Renal Failure

Intervention / Treatment
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* Drug: Cyclosporine discontinuation
* Drug: Rapamycin medication


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cyclosporine discontinuation|nan|
|Drug: Rapamycin medication|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function after 6 months (serum creatinine, calculated creatinine clearance) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  |  | 
| Rejection (clinical) |  |  | 
| Tolerability |  |  | 
| Blood pressure |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart transplantation, Renal failure, Cyclosporine, Rapamycin