Eplerenone's effect on blood vessel health in kidney transplant patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the impact of Eplerenone, a medication, on the progression of vascular issues in patients who have undergone kidney transplantation and are currently on cyclosporine. The study involves a crossover design where participants will receive Eplerenone at a dosage of 50mg per day for a specified period, followed by a period without the medication. The focus is on understanding how Eplerenone may help reduce arterial stiffness, a significant risk factor for cardiovascular mortality in this patient population. The trial aims to provide insights into improving cardiovascular outcomes for kidney transplant recipients.

Why it matters

Who can join: the full rules

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: 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 Criteria:

* 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.

Where it's running

• CHRU de Nancy
  Vandœuvre-lès-Nancy, France Recruiting

Study contacts

• Principal investigator: Sophie GIRERD, MD-PhD — Central Hospital, Nancy, France
• Study coordinator: Sophie GIRERD, MD-phD
• Email: s.girerd@chru-nancy.fr
• Phone: (0) 3 83 15 73 22

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using a closed-loop system to manage diabetes in kidney transplant patients

  This study is testing a new system that combines an insulin pump and glucose monitor to see if it can help manage blood sugar levels better in people with diabetes who have had a kidney transplant.

  Recruiting Shanxi Bethune Hospital · Taiyuan, Shanxi · NCT06962410

• Using imlifidase to help highly sensitized children receive kidney transplants

  This study is testing if a new treatment called imlifidase can help highly sensitized children with kidney failure get a transplant by changing their blood type compatibility.

  Recruiting at 4 sites Phase 2 Hansa Biopharma AB · Helsinki and 6 other locations · NCT05753930

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.