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