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

NCT ID: NCT00716573

Last Updated: 2017-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-16
• Study Completion Date: 2014-04-17

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

Conditions

Cardiac Transplantation; Chronic Renal Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: EXPERIMENTAL

everolimus

Intervention Type: DRUG

0,75 mg bid, 24 months

2

Maintain of their current immunosuppressive therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

everolimus

0,75 mg bid, 24 months

Intervention Type: DRUG

Other Intervention Names

Certican

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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pascale BOISSONNAT, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Hospices Civils de Lyon

Lyon, , France

Countries

France

Other Identifiers

2007.495

Identifier Type: -

Identifier Source: org_study_id