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

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.

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