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

Chronic Renal Insufficiency Clinical Trial

— COREV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00716573
• Other study ID #: 2007.495
• Status: Completed
• Phase: Phase 4
• First received: July 15, 2008
• Last updated: June 19, 2017
• Start date: September 16, 2008
• Est. completion date: April 17, 2014

Study information

• Verified date: June 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 17, 2014
• Est. primary completion date: April 17, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Transplantation
• Chronic Renal Insufficiency
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• everolimus
0,75 mg bid, 24 months

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the renal function, at 12 months after everolimus introduction and doses of anticalcineurins decrease.		12 months
Secondary	Evaluation of the benefit of everolimus introduction on renal function at 24 months		24 months
Secondary	Evaluation of the benefit of everolimus introduction on incidence of Major Adverse Cardiac Events (MACEs)		24 months
Secondary	Evaluation of the benefit of everolimus introduction on incidence of cardiovascular risk factor (Arterial Tension, diabetes, dyslipidemia, proteinuria)		24 months
Secondary	Evaluation of the benefit of everolimus introduction on incidence of treatment withdrawals		24 months
Secondary	Evaluation of the benefit of everolimus introduction on incidence of treated acute rejection		24 months
Secondary	Evaluation of the benefit of everolimus introduction on safety		24 months