Cardiac Improvement by Eplerenone Among Patients Under Cyclosporine or Tacrolimus for Kidney Transplantation.

NCT07828223 | Not Yet Recruiting Phase 3 DMC

• 2 other identifiers: 2019PI0922024-515860-29-00
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 3

Brief Summary

The main objective of this research is to evaluate the effect, for 36 weeks, of eplerenone on abnormalities observed on cardiac ultrasound in patients with kidney transplantation for at least one year, under cyclosporine or tacrolimus. The intervention group will receive the usual standard treatment coupled with eplerenone for 36 weeks from randomization, while the control group will only receive the standard treatment. The main hypothesis is that anticalcineurins (cyclosporin or tacrolimus) lead to activation of the MR of vascular smooth muscle cells, vasoconstriction and vascular inflammation, which contributes to the persistence or recurrence of heart abnormalities in these patients after the initial post-transplant phase. The administration of eplerenone could antagonize this hyperactivation, reduce the cardiovascular effects of anticalcineurins and thus ultimately improve the cardiovascular prognosis of transplant patients.

Conditions

Kidney Transplantation

Keywords

Eplérénone; Anticalcineurines; Kidney transplantation; cardiovascular

Outcome Measures

Primary Outcomes (1)

• Hierarchical composite endpoint (win ratio) : 1/ Death or hospitalization for heart failure or acute coronary syndrome, 2/ Variation in indexed left ventricular mass, 3/Variation in indexed left atrial volume.

  at 36 weeks

Secondary Outcomes (19)

• Evolution of Nt-ProBNP concentration

  randomization, at 12 and 36 weeks

• Evolution of collagen biomarkers (PICP )

  at 36 weeks

• Evolution of Biological markers of endothelial dysfunction (endothelin)

  at 36 weeks

• The occurrence of hyperkalaemia

  at 36 weeks

• Proportion of creatinine increase > 50%

  at 36 weeks

Study Arms (2)

Intervention group (under Eplerenone):

EXPERIMENTAL

Standard treatment according to usual care, combined with eplerenone for 36 weeks. Start of treatment with eplerenone at the initial dose of 25 mg/day, then adjusted according to clinical and biological tolerance: 12.5 mg/day (i.e., 25 mg/48h), 25 mg/day, and 50 mg/day.

Drug: Eplerenone

Controle group (without eplerenone):

NO INTERVENTION

Standard treatment according to usual care, it can or cannot include a renin-angiotensin system blocker, left to the discretion of the physician in charge of the patient.

Interventions

Eplerenone DRUG

The intervention group will receive standard treatment according to usual care, coupled with eplerenone for 36 weeks from randomization. Start of treatment with eplerenone at the initial dose of 25 mg/day, then adjusted according to clinical and biological tolerance: 12.5 mg/day (i.e., 25 mg/48h), 25 mg/day, and 50 mg/day.

Intervention group (under Eplerenone):

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (3)

CHU Nantes

Nantes, France

Location

CHU Strasbourg - nouvel hôpital Civil

Strasbourg, France

Location

CHRU Nancy - hôpital Brabois

Vandœuvre-lès-Nancy, France

Location

MeSH Terms

Interventions

Eplerenone

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Nicolas GIRERD, Md PhD

  CHRU NANCY

  STUDY CHAIR

Central Study Contacts

Nesrine BAILI, MD

CONTACT

+33 03 83 85 85 85; N.BAILI@chru-nancy.fr

Adrien FLAHAULT, Md PhD

CONTACT

A.FLAHAULT@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study chair

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: September 18, 2026

Record last verified: 2026-09

Locations

FR (3)