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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.
EU CTIS ID: 2024-515860-29-00
What this study is testing
To assess the impact of 36 weeks administration of eplerenone on a hierarchical composite endpoint including major cardiovascular events and cardiac structural changes in kidney transplant recipients for more than one year, receiving calcineurin inhibitors.
- 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
- Men or women ≥ 18 years of age.
- Patient affiliated to a social security scheme or beneficiary of such a scheme.
- Person who has undergone a prior clinical examination suitable for the clinical trial.
- Renal transplant patient for at least one year.
- Patient on long-term ciclosporin or tacrolimus therapy.
- Patient with a clinical and biological situation stable for at least three months: no change in treatment with a potential impact on blood pressure for 3 months (excluding immunosuppressive therapy) and no acute graft rejection diagnosed within 3 months
You likely can't join if
- Patient transplanted more than 5 years.
- Patients treated with digoxin.
- Left ventricular ejection fraction <40% on echocardiography at inclusion.
- Planned ligature of the arteriovenous fistula in the coming year.
- Known hypersensitivity or allergy to eplerenone and its excipients.
- Patients with severe hepatic impairment (Child-Pugh class C).
See the full eligibility criteria
Who can join
- Men or women ≥ 18 years of age.
- Patient affiliated to a social security scheme or beneficiary of such a scheme.
- Person who has undergone a prior clinical examination suitable for the clinical trial.
- Renal transplant patient for at least one year.
- Patient on long-term ciclosporin or tacrolimus therapy.
- Patient with a clinical and biological situation stable for at least three months: no change in treatment with a potential impact on blood pressure for 3 months (excluding immunosuppressive therapy) and no acute graft rejection diagnosed within 3 months
- Patient with a GFR estimated according to the CKD-EPI formula ≥40ml/min/1.73m2 less than one month old.
- Patient with peripheral SBP≥110mmHg, regardless of whether or not antihypertensive treatment (including ACE inhibitor or sartan) is being used.
- With the following echocardiographic abnormalities on trans-thoracic echocardiography performed at inclusion: - Indexed LV mass > 88 g/m2 in women or > 102 g/m2 in men, - And/or Left atrial volume > 34 ml/m2.
- Patient signed informed consent.
What rules you out
- Patient transplanted more than 5 years.
- Patients treated with digoxin.
- Left ventricular ejection fraction <40% on echocardiography at inclusion.
- Planned ligature of the arteriovenous fistula in the coming year.
- Known hypersensitivity or allergy to eplerenone and its excipients.
- Patients with severe hepatic impairment (Child-Pugh class C).
- Patient treated with a potent CYP3A4 inhibitor (e.g. itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, telithromycin and nefazodone).
- Patients with known galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome.
- Patients with a contraindication to Kayexalate: history of hypersensitivity to polystyrene sulphonate resins, obstructive intestinal pathology or laxative treatment with sorbitol.
- A woman of childbearing age without an effective contraceptive device : A woman is considered to be of childbearing age, i.e., fertile, from the onset of her first menstruation until she becomes menopausal, unless she is permanently sterile. An effective contraceptive method is considered to be: estrogen-progestogen hormonal contraception that inhibits ovulation, administered orally, intravaginally, or transdermally; or progestogen-only hormonal contraception that inhibits ovulation, administered orally, by injection, or implant; or intrauterine device (IUD) or hormonal IUD; or tubal ligation; or male partner with vasectomy; or sexual abstinence.
- Women wishing to become pregnant within 12 months.
- Patient in permanent atrial fibrillation.
- Patient taking part in other therapeutic interventional research.
- Pregnant woman, parturient or breast-feeding mother
- Minor child (not emancipated)
- An adult subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
- Persons deprived of their liberty by a judicial or administrative decision.
- Patient unable to express consent.
- Patient with valve disease grade 3 or higher.
- A patient whose risk of mortality is considered to be very high in the following year.
- Patients with documented kalaemia ≥ 5mmol/L in the month before or on long-term potassium chelating resins.
- Blood bicarbonate level < 20mmol/L with or without documented supplementation in the month before.
- Patient under mineralocorticoid receptor antagonist or with formal indication to receive this treatment.
- Patient receiving another potassium-sparing diuretic.
- Patients receiving a combination of ACE inhibitors and sartan.
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.
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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.