Can a heart drug shield transplant patients from their own medications?

NCT ID NCT07828223

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Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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First seen Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Kidney transplant recipients often take cyclosporine or tacrolimus to prevent rejection, but these drugs may contribute to heart changes such as thickened heart muscle and enlarged upper chambers. Researchers are testing whether adding eplerenone, a drug that blocks a hormone receptor, can improve these heart abnormalities. The trial enrolls adults who have had a kidney transplant for at least a year and are on stable cyclosporine or tacrolimus. Half receive eplerenone plus usual care for 36 weeks, and half receive usual care alone. The main measure combines death, heart failure hospitalization, heart attack, and changes in heart size seen on ultrasound.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
eplerenone, a drug that blocks the mineralocorticoid receptor
What this could lead to
If it works, eplerenone could become a routine add-on to protect the hearts of kidney transplant recipients who take cyclosporine or tacrolimus.
What could go wrong
This is a single trial in a specific group of stable transplant patients, so results may not apply to others. Eplerenone can raise potassium levels, which is a particular concern for people with kidney transplants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 132 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2027

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female with 18 years old or older. * Transplant patient for at least one year. * Patient on long-term cyclosporine or tacrolimus. * Patient whose clinical situation has been stable for at least 3 months, without major treatment modification and without an episode of acute rejection. * Patient with renal function with a GFR (glomerular filtration rate) greater than or equal to 40 ml/min/1.73m2. * Patient with systolic blood pressure greater than or equal to 110 mmHg, with or without antihypertensive treatment. * Patient with the following echocardiographic abnormalities at baseline : an left ventricular mass \> to 88 g/m2 in females or \> to 102 g/m2 in males and/or left atrial volume \> 34 ml/m2. Exclusion Criteria: * Kidney transplant recipient more than 5 years post-transplantation. * Patient with permanent atrial fibrillation. * Patient with valvular heart disease (grade ≥ 3). * Patient considered to be at very high risk of mortality within the next year. * Patient with documented serum potassium ≥ 5.0 mmol/L within the previous month or receiving long-term potassium-binding resin therapy. * Patient with documented serum bicarbonate \< 20 mmol/L within the previous month, with or without bicarbonate supplementation. * Patient receiving treatment with a mineralocorticoid receptor antagonist or having a formal indication for such treatment. * Patient receiving another potassium-sparing diuretic. * Patient receiving combined treatment with an ACE inhibitor and an angiotensin receptor blocker (each agent being permitted individually). * Patient receiving digoxin therapy. * Left ventricular ejection fraction (LVEF) \< 40% on the baseline echocardiographic assessment. * Planned closure of an existing arteriovenous fistula within the following year. * Known hypersensitivity or allergy to eplerenone or any of its excipients. * Patient with severe hepatic impairment (Child-Pugh class C). * Patient currently receiving treatment with a strong CYP3A4 inhibitor (e.g., itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, telithromycin, or nefazodone). * Patient with known galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption syndrome. * Patient with a contraindication to Kayexalate®: history of hypersensitivity to polystyrene sulfonate resins, obstructive bowel disease, or concomitant treatment with sorbitol-containing laxatives. * Woman of childbearing potential not using an effective method of contraception or planning to become pregnant within the next 12 months. * Patient participating in another interventional clinical study involving modifications to therapeutic management.

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As listed by the trial registrant

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How to take part

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  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • CHRU Nancy - hôpital Brabois

    Vandœuvre-lès-Nancy, France

  • CHU Nantes

    Nantes, France

  • CHU Strasbourg - nouvel hôpital Civil

    Strasbourg, France

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