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Efficacy Study of Everolimus on Renal Function in Heart Transplant Recipients With Established Chronic Renal Failure (COREV)
This study is currently recruiting participants.
Verified by Hospices Civils de Lyon, August 2009
First Received: July 15, 2008   Last Updated: August 12, 2009   History of Changes
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

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

Resource links provided by NLM:


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

No publications provided

Responsible Party: Hospices Civils de Lyon ( Pascale BOISSONNAT, MD )
Study ID Numbers: 2007.495
Study First Received: July 15, 2008
Last Updated: August 12, 2009
ClinicalTrials.gov Identifier: NCT00716573     History of Changes
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
Immunologic Factors
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Kidney Diseases
Immunosuppressive Agents
Kidney Failure

Additional relevant MeSH terms:
Everolimus
Renal Insufficiency
Immunologic Factors
Urologic Diseases
Renal Insufficiency, Chronic
Physiological Effects of Drugs
Kidney Failure, Chronic
Kidney Diseases
Immunosuppressive Agents
Pharmacologic Actions
Kidney Failure

ClinicalTrials.gov processed this record on September 10, 2009