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

Hospices Civils de Lyon1 site in 1 country120 target enrollmentSeptember 16, 2008

ConditionsCardiac Transplantation Chronic Renal Insufficiency

Interventionseverolimus

Drugseverolimus

Overview

Phase: Phase 4
Intervention: everolimus
Conditions: Cardiac Transplantation
Sponsor: Hospices Civils de Lyon
Enrollment: 120
Locations: 1
Primary Endpoint: Evaluation of the renal function, at 12 months after everolimus introduction and doses of anticalcineurins decrease.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

September 16, 2008

End Date

April 17, 2014

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hospices Civils de Lyon

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female cardiac recipients over 18 years old
•First or second heart transplant, more than one year following surgery
•Patients with renal failure assessed by cGFR 30 to 60 ml/min/1,73m² calculated by MDRD4 formula
•Patients volunteer to participate in the study, with a written informed consent signed
•Affiliation to a national health insurance program

Exclusion Criteria

•Current CNI-free immunosuppressive regimen
•Patients currently or previously treated with a mTOR inhibitor any time prior randomization
•Patients who are recipients for a multiple solid organ transplant
•Treated acute rejection episode within three months prior randomization
•Congestive heart failure (NYHA class III or IV) and/or VEF \< 30 % and/or patient waiting for a re-transplantation
•Scheduled surgical intervention
•Platelet count \< 50 G/l
•Severe hepatic insufficiency (SGPT and/or SGOT \> 3N)
•Major lipidic profile abnormalities (total cholesterol \> 3g/l and/or TG \> 5g/l)
•Proteinuria/creatinuria \> 0,08 g/mmol

Arms & Interventions

1

Introduction of everolimus associated with CNI (ciclosporin or tacrolimus) reduction (50%) to the current immunosuppression schedule

Intervention: everolimus

Outcomes

Primary Outcomes

Evaluation of the renal function, at 12 months after everolimus introduction and doses of anticalcineurins decrease.

Time Frame: 12 months

Secondary Outcomes

Evaluation of the benefit of everolimus introduction on renal function at 24 months(24 months)
Evaluation of the benefit of everolimus introduction on incidence of treatment withdrawals(24 months)
Evaluation of the benefit of everolimus introduction on incidence of cardiovascular risk factor (Arterial Tension, diabetes, dyslipidemia, proteinuria)(24 months)
Evaluation of the benefit of everolimus introduction on incidence of treated acute rejection(24 months)
Evaluation of the benefit of everolimus introduction on safety(24 months)
Evaluation of the benefit of everolimus introduction on incidence of Major Adverse Cardiac Events (MACEs)(24 months)