EVATRAN: Evaluation of the impact of Eplerenone on the VAscular stiffness in kidney TRANsplant récipients

Phase 1

• Conditions: Patients with a kidney transplantation for more than one year and on cyclosporine; MedDRA version: 20.0Level: SOCClassification code 10047065Term: Vascular disordersSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2019-004243-74-FR
• Lead Sponsor: Centre Hospitalier Régional Universitaire de Nancy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-31
• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

•Male or female = 50 years of age ;
•Patient who had a kidney transplant at least one year prior to inclusion;
•Patient treated with cyclosporine;
•Patient whose clinical-biological state has been stable for at least 3 months: no change in treatment with an impact on blood pressure (excluding immunosuppressive drug) for 3 months, no acute rejection diagnosed within 3 months;
•Patient with a glomerular filtration rate estimated according to the formula CKD-EPI =30mL/min/1.73m2;
•Patient with a peripheral PAS=110mmHg, irrespective of the presence or not of an antihypertensive therapy (including ACE inhibitors or sartan)
•Patient who signed informed consent;
•Patient affiliated with to beneficiary of a social security system.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 14
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22

Exclusion Criteria

•Patient with documented kalemia = 5mmol/L in the last 15 days,
•Bicarbonate blood level <20mmol/L with or without documented supplementation in the last 15 days,
•Patient undergoing mineralocorticoid receptor antagonism or with a formal indication to receive this treatment;
•Indication for a combination of ACE inhibitor and sartan or renin inhibitor (each of which is authorized separately);
Patient undergoing digoxin medication,
•Known hypersensitivity or allergy to eplerenone and its excipients;
•Patient with severe hepatic impairment (Child-Pugh Class C);
Patient treated with potent CYP3A4 inhibitor,
Patient with known galactose intolerance, lactase Lapp deficiency, or glucose, galactose malabsorption syndrom,
•Patient participating in other interventional research;
•Female with a desire of pregnancy for the next 15 months;
•Female of childbearing age without effective contraception;
•Persons referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code.
- Pregnant women, parturient women or nursing mothers ;
- Adult person subject to a legal protection measure (guardianship, curatorship, judicial safeguard);
- Adults person who is unable to give consent and who is not subject to a legal protection measure;
- Persons deprived of their liberty by a judicial or administrative decision;
- Persons subject to psychiatric care pursuant to articles L. 3212-1 and L. 3213-

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified