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NCT00170859 Clinical Trial

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

Heart Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00170859
Other study ID # CRAD001ADE01
Secondary ID
Status Completed
Phase Phase 4
First received September 9, 2005
Last updated November 16, 2016
Start date August 2004
Est. completion date December 2006

Study information
Verified date November 2016
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date December 2006
Est. primary completion date November 2006
Accepts healthy volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Everolimus

Locations
Country Name City State
Germany Novartis Investigational Site Various Cities

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Bara C, Dengler T, Hack MA, Ladenburger S, Lehmkuhl HB. A 1-year randomized controlled study of everolimus versus mycophenolate mofetil with reduced-dose cyclosporine in maintenance heart transplant recipients. Transplant Proc. 2013 Jul-Aug;45(6):2387-92. — View Citation

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Terminated NCT00121784 - Heart Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Heart Transplant Recipients Phase 4
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