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New treatment option for Kidney Transplantation for More Than One Year
Official title The Effect of Eplerenone on the Evolution of Vasculopathy in Renal Transplant Patients.
ClinicalTrials.gov ID: NCT04450953
What this study is testing
What is Eplerenone 50mg/day (cross over design)?
Eplerenone 50mg/day (cross over design) is an investigational medicine, being studied as a potential treatment for kidney transplantation for more than one year.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- Men or women ≥ 50 years of age;
- Patient who had a kidney transplant at least one year prior to inclusion;
- Patient on 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...
- Patient with a glomerular filtration rate estimated according to the formula CKD-EPI ≥30mL/min/1.73m2;
You likely can't join if
- Patient with documented kalemia ≥ 5mmol/L in the last 15 days;
- Patient undergoing mineralocorticoid receptor antagonism or with a formal indication to receive this treatment;
- Bicarbonate blood level \<20mmol/L with or without documented supplementation in the last 15 days.
- Indication for a combination of ACE inhibitor and sartan (each of which is authorized separately);
- Patient under another potassium sparing diuretics;
- Patient under digoxine;
See the full eligibility criteria
- Men or women ≥ 50 years of age;
- Patient who had a kidney transplant at least one year prior to inclusion;
- Patient on 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...
- 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 with signed informed consent;
- Patient affiliated with or beneficiary of a social security system.
- Patient with documented kalemia ≥ 5mmol/L in the last 15 days;
- Patient undergoing mineralocorticoid receptor antagonism or with a formal indication to receive this treatment;
- Bicarbonate blood level \<20mmol/L with or without documented supplementation in the last 15 days.
- Indication for a combination of ACE inhibitor and sartan (each of which is authorized separately);
- Patient under another potassium sparing diuretics;
- Patient under digoxine;
- Sodium polystyrene sulfonate contraindication;
- Known hypersensitivity or allergy to eplerenone and its excipients;
- Patient with severe hepatic impairment (Child-Pugh Class C);
- Patient under CYP3A4 inhibitor;
- know intolerance to Galactose, a Lapp lactase deficiency or galactose malabsorption syndrome;
- Patient participating in other treatment research;
- Woman with a desire of pregnancy within 15 months;
- Woman of childbearing age without effective contraception;
- Persons referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code :
- Pregnant women, parturient women or nursing mothers ;
- Adult person subject to a legal protection measure (guardianship, curator, 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.
The study team makes the final eligibility decision.
Where it's taking place
- Vandœuvre-lès-Nancy, France
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, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vandœuvre-lès-Nancy, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.