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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2005-04-30

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.

Conditions

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Heart Transplantation Renal Failure

Keywords

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Heart transplantation Renal failure Cyclosporine Rapamycin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Cyclosporine discontinuation

Intervention Type DRUG

Rapamycin medication

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Thomas J Dengler, MD

Role: PRINCIPAL_INVESTIGATOR

Heidelberg University

Locations

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Medizinische Universitätsklinik, Kardiologie

Heidelberg, , Germany

Site Status

Countries

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Germany

References

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Angermann CE, Stork S, Costard-Jackle A, Dengler TJ, Siebert U, Tenderich G, Rahmel A, Schwarz ER, Nagele H, Wagner FM, Haaff B, Pethig K. Reduction of cyclosporine after introduction of mycophenolate mofetil improves chronic renal dysfunction in heart transplant recipients--the IMPROVED multi-centre study. Eur Heart J. 2004 Sep;25(18):1626-34. doi: 10.1016/j.ehj.2004.06.032.

Reference Type BACKGROUND

PMID: 15351162 (View on PubMed)

Other Identifiers

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HD_cardio_352/2003_dengler

Identifier Type: -

Identifier Source: org_study_id