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

This study is currently recruiting participants.

Verified by Novartis, January 2009

Sponsored by:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00170859

Purpose

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 IV

MedlinePlus related topics: Heart Transplantation

Drug Information available for: Cyclosporin Cyclosporine Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Everolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Novartis:

Study Start Date:

August 2004

Eligibility

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00170859

Contacts

Contact: Novartis

41 61 324 1111

Locations

Germany
Novartis Investigational Site	Recruiting
Various Cities, Germany
Contact: Novartis 41 61 324 1111

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis

More Information

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CRAD001ADE01
Study First Received:	September 9, 2005
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00170859
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

everolimus
cyclosporine microemulsion
renal function

Study placed in the following topic categories:

Everolimus
Cyclosporine
Clotrimazole
Miconazole

Tioconazole
Mycophenolate mofetil
Cyclosporins

Additional relevant MeSH terms:

Anti-Infective Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antifungal Agents
Physiological Effects of Drugs

Enzyme Inhibitors
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009