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Completed

NCT Number: NCT00123331

Rapamycin Use in Calcineurin Inhibitor (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.

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Key information

Conditions

Heart Transplantation Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Failure Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medizinische Universitätsklinik, Kardiologie

Heidelberg, D-69115, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclosporine discontinuation

Drug

Rapamycin medication

Drug

Primary outcomes

  1. Renal function after 6 months (serum creatinine, calculated creatinine clearance)

Secondary outcomes

  1. Survival

  2. Rejection (clinical)

  3. Tolerability

  4. Blood pressure

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2005
First posted
Jul 22, 2005
Registry last updated
Aug 2, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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