NCT00716573

Efficacy Study of Everolimus on Renal Function in Heart Transplant Recipients With Established Chronic Renal Failure

COREV : A Multi-center, Randomized, Open-label Study Evaluating the Efficacy on Renal Function of Everolimus in Heart Transplant Recipients With Established Chronic Renal Failure

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

After transplantation, renal impairment, incidence and progression of atherosclerosis lead to modification of immunosuppressive regimens, as switch, reduction or discontinuation of CNI and/or introduction of everolimus. The risk or benefits of these strategies were not clearly evaluated by specific clinical trials. This study is specifically designed for evaluating the impact of everolimus introduction, with calcineurin dose reduction, at less one year after cardiac transplantation, on renal and clinical outcomes, specially on : * Renal function improvement * Vasculopathy and major cardiac event reduction * Maintenance of immunosuppressive efficacy

Conditions

• Cardiac Transplantation
• Chronic Renal Insufficiency

Interventions

Type	Name	Description
DRUG	everolimus	0,75 mg bid, 24 months

Timeline

• Start date: 2008-09-16
• Primary completion: 2014-04-17
• Completion: 2014-04-17
• First posted: 2008-07-16
• Last updated: 2017-06-20

Locations

1 site across 1 country: France