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

A Randomized Crossover Clinical Trial Regarding the Blockage of the Mineralocorticoid Receptor Using Eplerenone on the Evolution of Arterial Stiffness in Kidney Patients One Year After Transplant

This study is testing if the medication Eplerenone can help improve blood vessel health and reduce stiffness in kidney transplant patients who are taking cyclosporine.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Central Hospital, Nancy, France (Academic / other)
• Locations: 1 site (Vandœuvre-lès-Nancy)
• Trial ID: NCT04450953 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are men or women aged 50 and older who have had a kidney transplant for at least one year and are currently on cyclosporine.

Not a fit: Patients with recent high potassium levels or those already receiving mineralocorticoid receptor antagonism may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved cardiovascular health and reduced mortality rates in kidney transplant patients.

How similar studies have performed: While the specific approach of using Eplerenone in this context may be novel, similar studies have shown promise in addressing cardiovascular issues in kidney transplant patients.

Eligibility criteria

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 this trial is running

Vandœuvre-lès-Nancy

• 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

Conditions Kidney Transplantation for More Than One Year; Patients with a Kidney Transplantation on Cyclosporine