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

Civil Hospices of Lyon

Status and phase

Completed

Phase 4

Conditions

Cardiac Transplantation

Chronic Renal Insufficiency

Treatments

Drug: everolimus

Study type

Interventional

Funder types

Other

Identifiers

NCT00716573

2007.495

Details and patient eligibility

About

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

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
Severe renal failure attested by cGFR < 30 ml/min/1.73m² (MDRD4)
History of Hypersensitivity to everolimus, sirolimus or excipients
History of Hypersensitivity to macrolides
Pregnancy and breast feeding
Childbearing age women without efficient contraception
Law protected patients
Patients in emergency unable to express their consent
History of Hypersensitivity to cyclosporine or St-John's wort, stiripentol, bosentan, rosuvastatin
History of Hypersensitivity to tacrolimus, macrolides or excipients
History of Hypersensitivity to azathioprine
History of Hypersensitivity to mycophénolate mofetil or excipients