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NOT YET RECRUITING
NCT07828223
PHASE3

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

Sponsor: Central Hospital, Nancy, France

View on ClinicalTrials.gov

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.

Official title: Randomized Controlled Trial Evaluating the Impact of Mineralocorticoid Receptor Blockade by Eplerenone on Echocardiographic Abnormalities Among Kidney Graft Recipient Under Calcineurin Inhibitors. KT-CANOPY: Cardiac Improvement by Eplerenone Among Patients Under Cyclosporine or Tacrolimus for Kidney Transplantation.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

132

Start Date

2027-02

Completion Date

2030-12

Last Updated

2026-09-18

Healthy Volunteers

No

Interventions

DRUG

Eplerenone

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.

Locations (3)

CHU Nantes

Nantes, France

CHU Strasbourg - nouvel hôpital Civil

Strasbourg, France

CHRU Nancy - hôpital Brabois

Vandœuvre-lès-Nancy, France