Rapamycin Use in Calcineurin Inhibitor (CNI)-Free Immunosuppression for Stabilization/Improvement of Renal Function After Heart Transplantation
NCT00123331
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Adult Trials: 18+ Years
- Heart transplantation (> 6 months post-operation)
- Renal failure (serum creatinine stably > 1.7 mg/dl
- Cyclosporine trough blood level < 110 ng/ml
- < 18 years of age
- Rapamycin intolerability
- Active infection
- Pregnancy, breast feeding
- Major elective surgery planned in study period
- Thrombopenia < 100,000/ml
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Rapamycin Use in Calcineurin Inhibitor (CNI)-Free Immunosuppression for Stabilization/Improvement of Renal Function After Heart Transplantation | |||
| Official Title ICMJE | Rapamycin Use in CNI-Free Immunosuppression for Stabilization/Improvement of Renal Function After Heart Transplantation | |||
| 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 Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 4 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE | Not Provided | |||
| Publications * | 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | 40 | |||
| Original Enrollment ICMJE | Same as current | |||
| Study Completion Date ICMJE | April 2005 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Germany | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00123331 | |||
| Other Study ID Numbers ICMJE | HD_cardio_352/2003_dengler | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | Heidelberg University | |||
| Collaborators ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Investigators ICMJE |
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| PRS Account | Heidelberg University | |||
| Verification Date | June 2005 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||