Actively Recruiting

Phase 3
Age: 50Years +
All Genders
ID04450953

Effect of Eplerenone on Arterial Stiffness in Kidney Transplant Patients on Cyclosporine: A Randomized Crossover Trial

Led by Central Hospital, Nancy, France · Updated on 2025-02-12

36

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the effects of eplerenone, a mineralocorticoid receptor antagonist, on arterial stiffness in kidney transplant patients who are on calcineurin inhibitors like cyclosporine. Cardiovascular problems are a leading cause of death in these patients, even though transplant improves kidney function compared to dialysis. The study aims to understand if blocking this receptor can reduce arterial stiffness and improve cardiovascular outcomes in this group. Participants receive eplerenone 50 mg daily orally for 6 months, followed by an 8 to 10-week washout period and then a 6-month period without eplerenone, or vice versa in a randomized crossover design. This allows comparison of arterial stiffness evolution with and without eplerenone treatment over the study year. During the study, researchers will monitor pulse wave velocity and blood pressure measures, as well as heart structure and blood markers related to oxidative stress and endothelial function. Kidney function and proteinuria levels will also be assessed. Safety monitoring includes tracking hyperkalemia and changes in creatinine. The study lasts about one year per participant, including treatment and washout phases.

CONDITIONS

Brief Title

The Effect of Eplerenone on the Evolution of Vasculopathy in Renal Transplant Patients.

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men or women aged 50 years or older
  • Had a kidney transplant at least one year before joining the study
  • Currently taking cyclosporine
  • Stable clinical and biological status for at least 3 months with no recent changes in blood pressure treatments (except immunosuppressive drugs) and no acute rejection in 3 months
  • Estimated glomerular filtration rate of 30 mL/min/1.73m2 or higher
  • Peripheral systolic blood pressure of 110 mmHg or higher, with or without blood pressure medication
  • Signed informed consent
  • Affiliated with or beneficiary of a social security system
Not Eligible

You will not qualify if you...

  • Potassium levels of 5 mmol/L or higher in the last 15 days
  • Currently using mineralocorticoid receptor antagonists or have a formal reason to receive them
  • Blood bicarbonate level below 20 mmol/L recently
  • Need for combined ACE inhibitor and sartan therapy
  • Using other potassium-sparing diuretics
  • Taking digoxin
  • Contraindication to sodium polystyrene sulfonate
  • Allergy to eplerenone or its ingredients
  • Severe liver impairment (Child-Pugh Class C)
  • Taking CYP3A4 inhibitors
  • Known intolerance to galactose or related metabolic conditions
  • Participating in other interventional research
  • Women planning pregnancy within 15 months
  • Women of childbearing age without effective contraception
  • Pregnant, delivering, or nursing women
  • Adults under legal protection measures or unable to consent
  • Persons deprived of liberty by judicial or administrative decision
  • Persons under psychiatric care as defined by law

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Two 6-month treatment periods separated by an 8 to 10 week wash-out period

Participants receive eplerenone 50 mg/day taken orally for 6 months or undergo a 6-month period without eplerenone, followed by a wash-out period and crossover to the alternate treatment.

Visits occur throughout each treatment period and wash-out phase as scheduled by the study team

Trial Site Locations

Total: 1 location

1

CHRU de Nancy

Vandœuvre-lès-Nancy, France, 54500

Actively Recruiting

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Research Team

S

Sophie GIRERD, MD-phD

N

Nicolas GIRERD, MD-PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

Frequently Asked Questions

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Published Research Related To This Trial

EVATRAN (The Effect of Eplerenone on the Evolution of Vasculopathy in Renal Transplant Patients): study protocol for a cross-over randomized controlled trial.

Arnaud Simon, Nicolas Girerd, Frédéric Jaisser...

https://pubmed.ncbi.nlm.nih.gov/41204172