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The Effect of Eplerenone on the Evolution of Vasculopathy in Renal Transplant Patients. (EVATRAN)
EU CTIS ID: 2024-513808-34-00
What this study is testing
To evaluate the impact of a six month administration of eplerenone on arterial stiffness, among stable kidney transplant patients on cyclosporine, transplanted for at least one year
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female ≥ 50 years of age
- Patient who had a kidney transplant at least one year prior to inclusion
- Patient treated with cyclosporine
- Patient whose clinical-biological state has been stable for at least 3 months: no change in treatment with an impact on blood pressure (excluding immunosuppressive drug) for 3 months, no acute rejection diagnosed within 3 months
- Patient with a glomerular filtration rate estimated according to the formula CKD-EPI ≥30mL/min/1.73m2
- Patient with a peripheral PAS≥110mmHg, irrespective of the presence or not of an antihypertensive therapy (including ACE inhibitors or sartan)
You likely can't join if
- Patient with documented kalemia ≥ 5mmol/L in the last 15 days
- Patient with known galactose intolerance, lactase Lapp deficiency, or glucose, galactose malabsorption syndrom
- Contraindication to Sodium polystyrène sulfonate (potassium binder) administration : Intestinal obstructive disease and sorbitol laxative treatment
- Patient participating in other interventional research
- Female with a desire of pregnancy for the next 15 months
- Female of childbearing age without effective contraception
See the full eligibility criteria
- Male or female ≥ 50 years of age
- Patient who had a kidney transplant at least one year prior to inclusion
- Patient treated with cyclosporine
- Patient whose clinical-biological state has been stable for at least 3 months: no change in treatment with an impact on blood pressure (excluding immunosuppressive drug) for 3 months, no acute rejection diagnosed within 3 months
- Patient with a glomerular filtration rate estimated according to the formula CKD-EPI ≥30mL/min/1.73m2
- Patient with a peripheral PAS≥110mmHg, irrespective of the presence or not of an antihypertensive therapy (including ACE inhibitors or sartan)
- Patient who signed informed consent
- Patient affiliated with to beneficiary of a social security system
- Patient with documented kalemia ≥ 5mmol/L in the last 15 days
- Patient with known galactose intolerance, lactase Lapp deficiency, or glucose, galactose malabsorption syndrom
- Contraindication to Sodium polystyrène sulfonate (potassium binder) administration : Intestinal obstructive disease and sorbitol laxative treatment
- Patient participating in other interventional research
- Female with a desire of pregnancy for the next 15 months
- Female of childbearing age without effective contraception
- Pregnant women, parturient women or nursing mothers
- Adult person subject to a legal protection measure (guardianship, curatorship, judicial safeguard)
- Adults person who is unable to give consent and who is not subject to a legal protection measure
- Persons deprived of their liberty by a judicial or administrative decision
- persons subject to psychiatric care pursuant to articles L. 3212-1 and L. 3213-1
- Bicarbonate blood level <20mmol/L with or without documented supplementation in the last 15 days,
- Patient undergoing mineralocorticoid receptor antagonism or with a formal indication to receive this treatment
- Patients receiving potassium sparing diuretics
- Patients treated with a combination of ACEi and ARBs (each of which is authorized separately);
- Patient undergoing digoxin medication
- Known hypersensitivity or allergy to eplerenone and its excipients
- Patient with severe hepatic impairment (Child-Pugh Class C)
- Patient treated with potent CYP3A4 inhibitor (p.e. itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycine, télithromycine et nefazodone)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.