Actively Recruiting
The Effect of Eplerenone on the Evolution of Vasculopathy in Renal Transplant Patients.
Led by Central Hospital, Nancy, France · Updated on 2025-02-12
36
Participants Needed
1
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Cardiovascular (CV) pathologies are the leading cause of death in kidney transplant patients.Arterial stiffness is a prognostic factor for CV mortality in kidney transplantation. Despite a reduced CV risk in transplant kidney patients in comparison to patients in dialysis, CV mortality among kidney transplant patients is much higher than the general population. After renal transplantation, the cardiac and vascular anomalies observed in chronic end-stage renal disease are partially improved because of restored normal kidney function and withdrawal from dialysis. However, patients are exposed to immunosuppressive drugs, in particular calcineurin inhibitors, which can be associated with vascular toxicity, either directly or by promoting the appearance of hypertension, diabetes, or dyslipidemia.The pathophysiology of arterial stiffness in kidney transplantation is complex and multifactorial. Calcineurin inhibitors are likely to play an important role in the persistence of increased arterial stiffness in transplant patients in whom renal function has been restored. Indeed, the discontinuation of anti-calcineurins in favour of other molecules .is associated with a decrease of arterial stiffness. Preclinical work has shown that the vascular toxicity of cyclosporine is mediated by activation of the mineralocorticoid receptor in smooth muscle cells. The involvement of the mineralocorticoid receptor in the onset of arterial stiffness is also well demonstrated in non-transplanted subjects. Blocking the mineralocorticoid receptor in patients under cyclosporine may reduce their arterial stiffness and in and consequently improve their CV prognosis. Studies have show a good safety in kidney transplant patients. This pilot study proposes to examine, for the first time, the impact of treatment with a mineralocorticoid receptor antagonist on the evolution of arterial stiffness in renal transplant patients on calcineurin inhibitors.
CONDITIONS
Official Title
The Effect of Eplerenone on the Evolution of Vasculopathy in Renal Transplant Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women 50 years of age or older
- Kidney transplant received at least one year before joining the study
- Currently on cyclosporine treatment
- Stable clinical and biological condition for at least 3 months with no recent changes in blood pressure treatments (excluding immunosuppressants) or acute rejection
- Estimated glomerular filtration rate (CKD-EPI) of 30 mL/min/1.73m2 or higher
- Peripheral systolic blood pressure of 110 mmHg or higher, regardless of antihypertensive treatment
- Signed informed consent
- Affiliated with or beneficiary of a social security system
You will not qualify if you...
- Documented potassium level of 5 mmol/L or higher in the last 15 days
- Currently using mineralocorticoid receptor antagonists or have a formal indication for this treatment
- Blood bicarbonate level below 20 mmol/L in the last 15 days, with or without supplementation
- Indication for combined use of ACE inhibitor and sartan
- Using other potassium-sparing diuretics
- Taking digoxin
- Contraindication to sodium polystyrene sulfonate
- Known allergy or hypersensitivity to eplerenone or its components
- Severe liver impairment (Child-Pugh Class C)
- Using CYP3A4 inhibitors
- Known intolerance to galactose, Lapp lactase deficiency, or galactose malabsorption syndrome
- Participating in other interventional research
- Women planning pregnancy within 15 months
- Women of childbearing age without effective contraception
- Pregnant, breastfeeding, or recently delivered women
- Adults under legal protection measures or unable to give consent
- Persons deprived of liberty by judicial or administrative decision
- Persons under psychiatric care as defined by law
AI-Screening
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Trial Site Locations
Total: 1 location
1
CHRU de Nancy
Vandœuvre-lès-Nancy, France, 54500
Actively Recruiting
Research Team
S
Sophie GIRERD, MD-phD
CONTACT
N
Nicolas GIRERD, MD-PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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