The Effect of Eplerenone on the Evolution of Vasculopathy in Renal Transplant Patients. (EVATRAN)
- Conditions
- kidney transplantationTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2024-513808-34-00
- Lead Sponsor
- CHRU De Nancy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 36
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
Patient with documented kalemia = 5mmol/L in the last 15 days, Patient with known galactose intolerance, lactase Lapp deficiency, or glucose, galactose malabsorption syndrom, Contraindication to Sodium polystyrène sulfonate (potassium binder) administration : Intestinal obstructive disease and sorbitol laxative treatment, Patient participating in other interventional research, Female with a desire of pregnancy for the next 15 months, Female of childbearing age without effective contraception, 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. 3213-1, 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, Patients receiving potassium sparing diuretics, Patients treated with a combination of ACEi and ARBs (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 (p.e. itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycine, télithromycine et nefazodone)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method