The Effect of Eplerenone on the Evolution of Vasculopathy in Renal Transplant Patients.

Phase 3

Recruiting

• Conditions: Kidney Transplantation for More Than One Year; Patients With a Kidney Transplantation on Cyclosporine

• Registration Number: NCT04450953
• Lead Sponsor: Pr. Nicolas GIRERD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-6-25
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

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

Inclusion Criteria

Inclusion Criteria:<br><br> - Men or women = 50 years of age;<br><br> - Patient who had a kidney transplant at least one year prior to inclusion;<br><br> - Patient on cyclosporine;<br><br> - Patient whose clinical-biological state has been stable for at least 3 months: no<br> change in treatment with an impact on blood pressure (excluding immunosuppressive<br> drug) for 3 months, no acute rejection diagnosed within 3 months;<br><br> - Patient with a glomerular filtration rate estimated according to the formula CKD-EPI<br> =30mL/min/1.73m2;<br><br> - Patient with a peripheral PAS=110mmHg, irrespective of the presence or not of an<br> antihypertensive therapy (including ACE inhibitors or sartan) ;<br><br> - Patient with signed informed consent;<br><br> - Patient affiliated with or beneficiary of a social security system.<br><br>Exclusion Criteria:<br><br> - Patient with documented kalemia = 5mmol/L in the last 15 days;<br><br> - Patient undergoing mineralocorticoid receptor antagonism or with a formal indication<br> to receive this treatment;<br><br> - Bicarbonate blood level <20mmol/L with or without documented supplementation in the<br> last 15 days.<br><br> - Indication for a combination of ACE inhibitor and sartan (each of which is<br> authorized separately);<br><br> - Patient under another potassium sparing diuretics;<br><br> - Patient under digoxine;<br><br> - Sodium polystyrene sulfonate contraindication;<br><br> - Known hypersensitivity or allergy to eplerenone and its excipients;<br><br> - Patient with severe hepatic impairment (Child-Pugh Class C);<br><br> - Patient under CYP3A4 inhibitor;<br><br> - know intolerance to Galactose, a Lapp lactase deficiency or galactose malabsorption<br> syndrome;<br><br> - Patient participating in other interventional research;<br><br> - Woman with a desire of pregnancy within 15 months;<br><br> - Woman of childbearing age without effective contraception;<br><br> - Persons referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public<br> Health Code :<br><br> - Pregnant women, parturient women or nursing mothers ;<br><br> - Adult person subject to a legal protection measure (guardianship, curator, judicial<br> safeguard);<br><br> - Adults person who is unable to give consent and who is not subject to a legal<br> protection measure;<br><br> - Persons deprived of their liberty by a judicial or administrative decision;<br><br> - Persons subject to psychiatric care pursuant to articles L. 3212-1 and L. 3213-1.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evolution of pulse wave velocity (PWV in m/s) adjusted to the blood pressure