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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00123331
First Posted: July 22, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Heidelberg University
  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
Intervention Model: Parallel Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: July 18, 2005
First Posted: July 22, 2005
Last Update Posted: December 9, 2005
Last Verified: June 2005

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
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Anti-Bacterial Agents
Antibiotics, Antineoplastic
Antineoplastic Agents