Phase
Condition
N/ATreatment
Eplerenone 50mg/day (cross over design)
Period without eplerenone (cross over design)
Clinical Study ID
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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: nochange in treatment with an impact on blood pressure (excluding immunosuppressivedrug) 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 anantihypertensive therapy (including ACE inhibitors or sartan) ;
Patient with signed informed consent;
Patient affiliated with or beneficiary of a social security system.
Exclusion
Exclusion Criteria:
Patient with documented kalemia ≥ 5mmol/L in the last 15 days;
Patient undergoing mineralocorticoid receptor antagonism or with a formal indicationto receive this treatment;
Bicarbonate blood level <20mmol/L with or without documented supplementation in thelast 15 days.
Indication for a combination of ACE inhibitor and sartan (each of which isauthorized 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 malabsorptionsyndrome;
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 PublicHealth Code :
Pregnant women, parturient women or nursing mothers ;
Adult person subject to a legal protection measure (guardianship, curator, judicialsafeguard);
Adults person who is unable to give consent and who is not subject to a legalprotection 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.
Study Design
Connect with a study center
CHRU de Nancy
Vandœuvre-lès-Nancy, 54500
FranceActive - Recruiting
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