Clinical trial NCT00123331: Rapamycin Use in Calcineurin Inhibitor (CNI)-Free Immunosuppression for Stabilization/Improvement of Renal Function After Heart Transplantation
Official title: Rapamycin Use in CNI-Free Immunosuppression for Stabilization/Improvement of Renal Function After Heart Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Transplantation
Renal Failure
Keywords: Heart transplantation
Renal failure
Cyclosporine
Rapamycin
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2005-07-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Renal function after 6 months (serum creatinine, calculated creatinine clearance)
Secondary outcomes:
measure: Survival
measure: Rejection (clinical)
measure: Tolerability
measure: Blood pressure
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Medizinische Universitätsklinik, Kardiologie
Study officials:
affiliation: Heidelberg University
name: Thomas J Dengler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Angermann CE, Stork S, Costard-Jackle A, Dengler TJ, Siebert U, Tenderich G, Rahmel A, Schwarz ER, Nagele 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. doi: 10.1016/j.ehj.2004.06.032.