NCT00716573

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 16, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

September 16, 2008

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2014

Completed
Last Updated

June 20, 2017

Status Verified

June 1, 2017

Enrollment Period

5.6 years

First QC Date

July 15, 2008

Last Update Submit

June 19, 2017

Conditions

Cardiac TransplantationChronic Renal Insufficiency

Keywords

Cardiac transplantationChronic renal insufficiencyEverolimus

Outcome Measures

Primary Outcomes (1)

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

    12 months

Secondary Outcomes (6)

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

    24 months

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

    24 months

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

    24 months

  • Evaluation of the benefit of everolimus introduction on incidence of treatment withdrawals

    24 months

  • Evaluation of the benefit of everolimus introduction on incidence of treated acute rejection

    24 months

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

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

Drug: everolimus

2

NO INTERVENTION

Maintain of their current immunosuppressive therapy

Interventions

everolimusDRUG

0,75 mg bid, 24 months

Also known as: Certican
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Lyon, France

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Pascale BOISSONNAT, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2008

First Posted

July 16, 2008

Study Start

September 16, 2008

Primary Completion

April 17, 2014

Study Completion

April 17, 2014

Last Updated

June 20, 2017

Record last verified: 2017-06

Locations

FR(1)