Status:
RECRUITING
The Effect of Eplerenone on the Evolution of Vasculopathy in Renal Transplant Patients.
Lead Sponsor:
Central Hospital, Nancy, France
Conditions:
Kidney Transplantation for More Than One Year
Patients with a Kidney Transplantation on Cyclosporine
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
Cardiovascular (CV) pathologies are the leading cause of death in kidney transplant patients.Arterial stiffness is a prognostic factor for CV mortality in kidney transplantation. Despite a reduced CV ...
Eligibility Criteria
Inclusion
- Men or women ≥ 50 years of age;
- Patient who had a kidney transplant at least one year prior to inclusion;
- Patient on 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 with signed informed consent;
- Patient affiliated with or beneficiary of a social security system.
Exclusion
- Patient with documented kalemia ≥ 5mmol/L in the last 15 days;
- Patient undergoing mineralocorticoid receptor antagonism or with a formal indication to receive this treatment;
- Bicarbonate blood level \<20mmol/L with or without documented supplementation in the last 15 days.
- Indication for a combination of ACE inhibitor and sartan (each of which is authorized separately);
- Patient under another potassium sparing diuretics;
- Patient under digoxine;
- Sodium polystyrene sulfonate contraindication;
- Known hypersensitivity or allergy to eplerenone and its excipients;
- Patient with severe hepatic impairment (Child-Pugh Class C);
- Patient under CYP3A4 inhibitor;
- know intolerance to Galactose, a Lapp lactase deficiency or galactose malabsorption syndrome;
- Patient participating in other interventional research;
- Woman with a desire of pregnancy within 15 months;
- Woman 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, curator, 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. 3213-1.
Key Trial Info
Start Date :
October 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04450953
Start Date
October 12 2021
End Date
November 1 2025
Last Update
February 12 2025
Active Locations (1)
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1
CHRU de Nancy
Vandœuvre-lès-Nancy, France, 54500