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NCT00123331 Clinical Trial

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

Renal Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00123331
Other study ID # HD_cardio_352/2003_dengler
Secondary ID
Status Completed
Phase Phase 4
First received July 18, 2005
Last updated August 1, 2005
Start date October 2003
Est. completion date April 2005

Study information
Verified date June 2005
Source Heidelberg University
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date April 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Cyclosporine discontinuation

• Rapamycin medication

Locations
Country Name City State
Germany Medizinische Universitätsklinik, Kardiologie Heidelberg

Sponsors (2)
Lead Sponsor Collaborator
Heidelberg University Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Angermann CE, Störk S, Costard-Jäckle A, Dengler TJ, Siebert U, Tenderich G, Rahmel A, Schwarz ER, Nägele 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Renal function after 6 months (serum creatinine, calculated creatinine clearance)
Secondary Survival
Secondary Rejection (clinical)
Secondary Tolerability
Secondary Blood pressure
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