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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00716573
Other study ID # 2007.495
Secondary ID
Status Completed
Phase Phase 4
First received July 15, 2008
Last updated June 19, 2017
Start date September 16, 2008
Est. completion date April 17, 2014

Study information

Verified date June 2017
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date April 17, 2014
Est. primary completion date April 17, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
everolimus
0,75 mg bid, 24 months

Locations

Country Name City State
France Hospices Civils de Lyon Lyon

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of the renal function, at 12 months after everolimus introduction and doses of anticalcineurins decrease. 12 months
Secondary Evaluation of the benefit of everolimus introduction on renal function at 24 months 24 months
Secondary Evaluation of the benefit of everolimus introduction on incidence of Major Adverse Cardiac Events (MACEs) 24 months
Secondary Evaluation of the benefit of everolimus introduction on incidence of cardiovascular risk factor (Arterial Tension, diabetes, dyslipidemia, proteinuria) 24 months
Secondary Evaluation of the benefit of everolimus introduction on incidence of treatment withdrawals 24 months
Secondary Evaluation of the benefit of everolimus introduction on incidence of treated acute rejection 24 months
Secondary Evaluation of the benefit of everolimus introduction on safety 24 months
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