Efficacy Study of Everolimus on Renal Function in Heart Transplant Recipients With Established Chronic Renal Failure - Full Text View

Sponsored by:	Hospices Civils de Lyon
Information provided by:	Hospices Civils de Lyon
ClinicalTrials.gov Identifier:	NCT00716573

Purpose

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

Condition	Intervention	Phase
Cardiac Transplantation Chronic Renal Insufficiency	Drug: everolimus	Phase IV

MedlinePlus related topics: Heart Transplantation Hospice Care Kidney Failure

Drug Information available for: Everolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:

Evaluation of the renal function, at 12 months after everolimus introduction and doses of anticalcineurins decrease. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluation of the benefit of everolimus introduction on renal function at 24 months [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Evaluation of the benefit of everolimus introduction on incidence of Major Adverse Cardiac Events (MACEs) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Evaluation of the benefit of everolimus introduction on incidence of cardiovascular risk factor (Arterial Tension, diabetes, dyslipidemia, proteinuria) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Evaluation of the benefit of everolimus introduction on incidence of treatment withdrawals [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Evaluation of the benefit of everolimus introduction on incidence of treated acute rejection [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Evaluation of the benefit of everolimus introduction on safety [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	206
Study Start Date:	July 2008
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Introduction of everolimus associated with CNI (ciclosporin or tacrolimus) reduction (50%) to the current immunosuppression schedule	Drug: everolimus 0,75 mg bid, 24 months
2: No Intervention Maintain of their current immunosuppressive therapy

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00716573

Contacts

Contact: Pascale BOISSONNAT, MD

472 357 267 ext 33

pascale.boissonnat@chu-lyon.fr

Locations

France
Hospices Civils de Lyon	Recruiting
Lyon, France
Contact: Pascale BOISSONNAT, MD 472 357 267 ext 33 pascale.boissonnat@chu-lyon.fr
Principal Investigator: Pascale BOISSONNAT, MD

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator:

Pascale BOISSONNAT, MD

Hospices Civils de Lyon

More Information

Responsible Party:	Hospices Civils de Lyon ( Pascale BOISSONNAT, MD )
Study ID Numbers:	2007.495
Study First Received:	July 15, 2008
Last Updated:	November 21, 2008
ClinicalTrials.gov Identifier:	NCT00716573
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Hospices Civils de Lyon:

Cardiac transplantation
Chronic renal insufficiency
Everolimus

Study placed in the following topic categories:

Everolimus
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009