NCT00596557

Everolimus and Low Dose CNI Compared With MMF and Full CNI Dose in Heart Transplanted Patients: One Year Follow up

Phase IV: Effect of Everolimus and CNI Minimalization on Renal Function.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The different mechanisms of action of Everolimus and cyclosporine suppress immune function in synergistic manner. Thus it is postulated that the use of Everolimus in combination with cyclosporine permits a significant cyclosporine dose reduction without loss of immunosuppressive activity in the clinical setting. The aim of the present study is to evaluate the evolution of renal function after initiation of Everolimus and minimalisation of CNI dose.

Detailed description

Everolimus is a new proliferation signal inhibitor with immunosuppressive and antiproliferative activity. The mechanism of action of Everolimus is distinct from that of calcineurin inhibitors. Cardiac allograft vasculopathy is the major cause of late death in cardiac transplant patients. The different mechanisms of action of Everolimus and cyclosporine suppress immune function in synergistic manner. Thus it is postulated that the use of Everolimus in combination with cyclosporine permits a significant cyclosporine dose reduction without loss of immunosuppressive activity in the clinical setting. The aim of the present study is to evaluate the evolution of renal function after initiation of Everolimus and minimalisation of CNI dose.

Conditions

• Chronic Rejection of Cardiac Transplant

Interventions

Type	Name	Description
DRUG	everolimus	reduced dose CNI (cyclosporine level of 50-100)with everolimus levels of 3-8.

Timeline

• Start date: 2008-02-01
• Primary completion: 2009-02-01
• Completion: 2011-07-01
• First posted: 2008-01-17
• Last updated: 2011-07-29

Locations

1 site across 1 country: Israel