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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00716573
First received: July 15, 2008
Last updated: March 8, 2012
Last verified: December 2010
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

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 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

  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

Locations
France
Hospices Civils de Lyon
Lyon, France
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
ClinicalTrials.gov Identifier: NCT00716573     History of Changes
Other Study ID Numbers: 2007.495
Study First Received: July 15, 2008
Last Updated: March 8, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
 Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 23, 2013