Heart Transplantation, Renal Failure
Conditions
Keywords
Heart transplantation, Renal failure, Cyclosporine, Rapamycin
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.
Interventions
DRUGCyclosporine discontinuation
DRUGRapamycin medication
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Heidelberg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Renal function after 6 months (serum creatinine, calculated creatinine clearance) | — |
Secondary
| Measure | Time frame |
|---|---|
| Survival | — |
| Rejection (clinical) | — |
| Tolerability | — |
| Blood pressure | — |
Countries
Germany
Outcome results
None listed