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

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00123331
First received: July 18, 2005
Last updated: August 1, 2005
Last verified: June 2005
  Purpose

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.


Condition Intervention Phase
Heart Transplantation
Renal Failure
Drug: Cyclosporine discontinuation
Drug: Rapamycin medication
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Rapamycin Use in CNI-Free Immunosuppression for Stabilization/Improvement of Renal Function After Heart Transplantation

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Renal function after 6 months (serum creatinine, calculated creatinine clearance)

Secondary Outcome Measures:
  • Survival
  • Rejection (clinical)
  • Tolerability
  • Blood pressure

Estimated Enrollment: 40
Study Start Date: October 2003
Estimated Study Completion Date: April 2005
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123331

Locations
Germany
Medizinische Universitätsklinik, Kardiologie
Heidelberg, Germany, D-69115
Sponsors and Collaborators
Heidelberg University
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: Thomas J Dengler, MD Heidelberg University
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00123331     History of Changes
Other Study ID Numbers: HD_cardio_352/2003_dengler
Study First Received: July 18, 2005
Last Updated: August 1, 2005
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Heidelberg University:
Heart transplantation
Renal failure
Cyclosporine
Rapamycin

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Cyclosporins
Cyclosporine
Sirolimus
Everolimus
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Anti-Bacterial Agents
Antibiotics, Antineoplastic
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 19, 2014