Renal Failure Clinical Trial
Official title:
Rapamycin Use in CNI-Free Immunosuppression for Stabilization/Improvement of Renal Function After Heart Transplantation
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Medizinische Universitätsklinik, Kardiologie | Heidelberg |
Lead Sponsor | Collaborator |
---|---|
Heidelberg University | Wyeth is now a wholly owned subsidiary of Pfizer |
Germany,
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
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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