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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2010 by Hospices Civils de Lyon.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Hospices Civils de Lyon Identifier:
First received: July 15, 2008
Last updated: March 8, 2012
Last verified: December 2010

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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 ]

Secondary Outcome Measures:
  • Evaluation of the benefit of everolimus introduction on renal function at 24 months [ Time Frame: 24 months ]
  • Evaluation of the benefit of everolimus introduction on incidence of Major Adverse Cardiac Events (MACEs) [ Time Frame: 24 months ]
  • Evaluation of the benefit of everolimus introduction on incidence of cardiovascular risk factor (Arterial Tension, diabetes, dyslipidemia, proteinuria) [ Time Frame: 24 months ]
  • Evaluation of the benefit of everolimus introduction on incidence of treatment withdrawals [ Time Frame: 24 months ]
  • Evaluation of the benefit of everolimus introduction on incidence of treated acute rejection [ Time Frame: 24 months ]
  • Evaluation of the benefit of everolimus introduction on safety [ Time Frame: 24 months ]

Estimated Enrollment: 206
Study Start Date: July 2008
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Introduction of everolimus associated with CNI (ciclosporin or tacrolimus) reduction (50%) to the current immunosuppression schedule
Drug: everolimus
0,75 mg bid, 24 months
Other Name: Certican
No Intervention: 2
Maintain of their current immunosuppressive therapy


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00716573

Hospices Civils de Lyon
Lyon, France
Sponsors and Collaborators
Hospices Civils de Lyon
Principal Investigator: Pascale BOISSONNAT, MD Hospices Civils de Lyon
  More Information

Responsible Party: Hospices Civils de Lyon Identifier: NCT00716573     History of Changes
Other Study ID Numbers: 2007.495
Study First Received: July 15, 2008
Last Updated: March 8, 2012

Keywords provided by Hospices Civils de Lyon:
Cardiac transplantation
Chronic renal insufficiency

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents processed this record on April 28, 2017