search
Back to results

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

Primary Purpose

Cardiac Transplantation, Chronic Renal Insufficiency

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
everolimus
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Transplantation focused on measuring Cardiac transplantation, Chronic renal insufficiency, Everolimus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospices Civils de Lyon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Introduction of everolimus associated with CNI (ciclosporin or tacrolimus) reduction (50%) to the current immunosuppression schedule

Maintain of their current immunosuppressive therapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Evaluation of the benefit of everolimus introduction on renal function at 24 months
Evaluation of the benefit of everolimus introduction on incidence of Major Adverse Cardiac Events (MACEs)
Evaluation of the benefit of everolimus introduction on incidence of cardiovascular risk factor (Arterial Tension, diabetes, dyslipidemia, proteinuria)
Evaluation of the benefit of everolimus introduction on incidence of treatment withdrawals
Evaluation of the benefit of everolimus introduction on incidence of treated acute rejection
Evaluation of the benefit of everolimus introduction on safety

Full Information

First Posted
July 15, 2008
Last Updated
June 19, 2017
Sponsor
Hospices Civils de Lyon
search

1. Study Identification

Unique Protocol Identification Number
NCT00716573
Brief Title
Efficacy Study of Everolimus on Renal Function in Heart Transplant Recipients With Established Chronic Renal Failure
Acronym
COREV
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
September 16, 2008 (Actual)
Primary Completion Date
April 17, 2014 (Actual)
Study Completion Date
April 17, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Transplantation, Chronic Renal Insufficiency
Keywords
Cardiac transplantation, Chronic renal insufficiency, Everolimus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Introduction of everolimus associated with CNI (ciclosporin or tacrolimus) reduction (50%) to the current immunosuppression schedule
Arm Title
2
Arm Type
No Intervention
Arm Description
Maintain of their current immunosuppressive therapy
Intervention Type
Drug
Intervention Name(s)
everolimus
Other Intervention Name(s)
Certican
Intervention Description
0,75 mg bid, 24 months
Primary Outcome Measure Information:
Title
Evaluation of the renal function, at 12 months after everolimus introduction and doses of anticalcineurins decrease.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Evaluation of the benefit of everolimus introduction on renal function at 24 months
Time Frame
24 months
Title
Evaluation of the benefit of everolimus introduction on incidence of Major Adverse Cardiac Events (MACEs)
Time Frame
24 months
Title
Evaluation of the benefit of everolimus introduction on incidence of cardiovascular risk factor (Arterial Tension, diabetes, dyslipidemia, proteinuria)
Time Frame
24 months
Title
Evaluation of the benefit of everolimus introduction on incidence of treatment withdrawals
Time Frame
24 months
Title
Evaluation of the benefit of everolimus introduction on incidence of treated acute rejection
Time Frame
24 months
Title
Evaluation of the benefit of everolimus introduction on safety
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascale BOISSONNAT, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Lyon
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs