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Everolimus Versus Mycophenolate Mofetil in Combination With Reduced Dose Cyclosporine Microemulsion in Maintenance Heart Transplant Recipients

This study has been completed.
Information provided by:
Novartis Identifier:
First received: September 9, 2005
Last updated: June 15, 2011
Last verified: June 2011

In this study two immunosuppressive regimens (everolimus in combination with cyclosporine microemulsion and mycophenolate mofetil with cyclosporine microemulsion) with reduced dose cyclosporine microemulsion are compared in maintenance heart transplant recipients with impaired renal function.

Condition Intervention Phase
Heart Transplantation
Drug: Everolimus
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A One-year Multicenter, Randomized, Open-label Study of the Safety and Efficacy of Everolimus Versus Mycophenolate Mofetil in Combination With Reduced Dose Cyclosporine Microemulsion in Maintenance Heart Transplant Recipients

Resource links provided by NLM:

Further study details as provided by Novartis:

Study Start Date: August 2004
Study Completion Date: December 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both

Inclusion Criteria:

  • Recipients of primary heart transplant
  • Reduced renal function (serum creatinine > 1.7 ng/mL over 2 months or more) at 6 months or more after heart transplantation
  • Patients with current immunosuppressive therapy consisting of cyclosporine microemulsion and mycophenolate mofetil

Exclusion Criteria:

  • Patients who are recipients of multiple organ transplants
  • Patients who have previously received an organ transplant
  • Patients with serum creatinine > 3.5 mg/dl

Other protocol-defined exclusion criteria may apply.

  Contacts and Locations
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Please refer to this study by its identifier: NCT00170859

Novartis Investigational Site
Various Cities, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Novartis
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals Identifier: NCT00170859     History of Changes
Other Study ID Numbers: CRAD001ADE01
Study First Received: September 9, 2005
Last Updated: June 15, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
cyclosporine microemulsion
renal function

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 24, 2014