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Completed

NCT Number: NCT00716573

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

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

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Key information

Conditions

Cardiac Transplantation Chronic Disease Chronic Renal Insufficiency Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospices Civils de Lyon

Lyon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Everolimus

Drug

0,75 mg bid, 24 months

Other names: Certican

Primary outcomes

  1. Evaluation of the renal function, at 12 months after everolimus introduction and doses of anticalcineurins decrease.

    Time frame: 12 months

Secondary outcomes

  1. Evaluation of the benefit of everolimus introduction on renal function at 24 months

    Time frame: 24 months

  2. Evaluation of the benefit of everolimus introduction on incidence of Major Adverse Cardiac Events (MACEs)

    Time frame: 24 months

  3. Evaluation of the benefit of everolimus introduction on incidence of cardiovascular risk factor (Arterial Tension, diabetes, dyslipidemia, proteinuria)

    Time frame: 24 months

  4. Evaluation of the benefit of everolimus introduction on incidence of treatment withdrawals

    Time frame: 24 months

  5. Evaluation of the benefit of everolimus introduction on incidence of treated acute rejection

    Time frame: 24 months

  6. Evaluation of the benefit of everolimus introduction on safety

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study 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

Acronym: COREV

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Jul 16, 2008
Registry last updated
Jun 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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