Kidney TransplantationPhase 3KT-CANOPYNCT07828223
Cardiac Improvement by Eplerenone Among Patients Under Cyclosporine or Tacrolimus for Kidney Transplantation.
A Phase 3 study testing Eplerenone in people with Kidney Transplantation, run by Central Hospital, Nancy, France at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Eplerenone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 3 sitesFrance
- Study dates
- Feb 2027to Dec 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female with 18 years old or older.
- Transplant patient for at least one year.
- Patient on long-term cyclosporine or tacrolimus.
- Patient whose clinical situation has been stable for at least 3 months, without major treatment modification and without an episode of acute rejection.
- Patient with renal function with a GFR (glomerular filtration rate) greater than or equal to 40 ml/min/1.73m2.
- Patient with systolic blood pressure greater than or equal to 110 mmHg, with or without antihypertensive treatment.
- Patient with the following echocardiographic abnormalities at baseline : an left ventricular mass > to 88 g/m2 in females or > to 102 g/m2 in males and/or left atrial volume > 34 ml/m2.
Who cannot join
- Kidney transplant recipient more than 5 years post-transplantation.
- Patient with permanent atrial fibrillation.
- Patient with valvular heart disease (grade ≥ 3).
- Patient considered to be at very high risk of mortality within the next year.
- Patient with documented serum potassium ≥ 5.0 mmol/L within the previous month or receiving long-term potassium-binding resin therapy.
- Patient with documented serum bicarbonate < 20 mmol/L within the previous month, with or without bicarbonate supplementation.
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- Patient receiving treatment with a mineralocorticoid receptor antagonist or having a formal indication for such treatment.
- Patient receiving another potassium-sparing diuretic.
- Patient receiving combined treatment with an ACE inhibitor and an angiotensin receptor blocker (each agent being permitted individually).
- Patient receiving digoxin therapy.
- Left ventricular ejection fraction (LVEF) < 40% on the baseline echocardiographic assessment.
- Planned closure of an existing arteriovenous fistula within the following year.
- Known hypersensitivity or allergy to eplerenone or any of its excipients.
- Patient with severe hepatic impairment (Child-Pugh class C).
- Patient currently receiving treatment with a strong CYP3A4 inhibitor (e.g., itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, telithromycin, or nefazodone).
- Patient with known galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption syndrome.
- Patient with a contraindication to Kayexalate®: history of hypersensitivity to polystyrene sulfonate resins, obstructive bowel disease, or concomitant treatment with sorbitol-containing laxatives.
- Woman of childbearing potential not using an effective method of contraception or planning to become pregnant within the next 12 months.
- Patient participating in another interventional clinical study involving modifications to therapeutic management.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Adrien FLAHAULT, Md PhD contact
France3 sites
CHU Nantes
Nantes
Simon VILLE, +33 02 40 08 33 33, simon.ville@chu-nantes.fr
Simon VILLE, MD PhD
CHU Strasbourg - nouvel hôpital Civil
Strasbourg
Nans FLORENS, +33 3 88 11 67 68, nans.florens@chru-strasbourg.fr
Nans FLORENS, MD PhD
CHRU Nancy - hôpital Brabois
Vandœuvre-lès-Nancy
Nesrine BAILI, MD, +33 3 83 85 85 85, N.BAILI@chru-nancy.fr
Nesrine BAILI
About this study
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.
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.
- Conditions
- Kidney Transplantation
- Being tested
- Eplerenone
- Keywords
- Eplérénone, Anticalcineurines, Kidney transplantation, cardiovascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EplerenoneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (under Eplerenone): | Experimental | Standard treatment according to usual care, combined with eplerenone for 36 weeks. 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. Receives: Drug: Eplerenone |
| Controle group (without eplerenone): | No intervention | Standard treatment according to usual care, it can or cannot include a renin-angiotensin system blocker, left to the discretion of the physician in charge of the patient. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hierarchical composite endpoint (win ratio) : 1/ Death or hospitalization for heart failure or acute coronary syndrome, 2/ Variation in indexed left ventricular mass, 3/Variation in indexed left atrial volume.
Measured: at 36 weeks
Secondary outcomes (19)
Evolution of Nt-ProBNP concentration
Measured: randomization, at 12 and 36 weeks
Evolution of collagen biomarkers (PICP )
Measured: at 36 weeks
Evolution of Biological markers of endothelial dysfunction (endothelin)
Measured: at 36 weeks
The occurrence of hyperkalaemia
hyperkalaemia between 5 - 5.49; 5.5 - 6; >6mmol/L
Measured: at 36 weeks
Proportion of creatinine increase > 50%
Assessment of the proportion of acute kidney injury (AKI), defined as a >50% increase in serum creatinine from baseline.
Measured: at 36 weeks
Evolution of parameters of systolic function (LVEF, strain)
Measured: at 36 weeks
Evolution of parameters of remodeling (left ventricular volume)
Measured: at 36 weeks
Evolution of parameters of filling pressures (E/e')
Measured: at 36 weeks
Evolution of peripheral systolic blood pressure (mmHg)
Measured: at 36 weeks
Evolution of peripheral diastolic blood pressure (mmHg)
Measured: at 36 weeks
Evolution of peripheral pulse pressure (mmHg)
Measured: at 36 weeks
Evolution of Graft function assessed with serum creatinine (micromol/L)
Graft function assessed with serum creatinine with estimation of glomerular filtration rate according to the CKD-EPI formula.
The percentage of patients with GFR ≥ 90, 60-89, 45-59, 30-44, 15-29, <15ml/min/1.73m2 will also be assessed.
Measured: at 36 weeks
Evolution of proteinuria (mg/g)
Proteinuria measured by the proteinuria/creatininuria ratio. The percentage of patients with proteinuria/creatininuria ratio <500; 500-1000, 1000-2000, 2000-3000, >3000mg/g will also be assessed.
Measured: at 36 weeks
Evolution of parameters of remodeling (left atrial volumes)
Measured: at 36 weeks
Evolution of collagen biomarkers ( PIIINP)
Measured: at 36 weeks
Evolution of Biological markers of endothelial dysfunction ( soluble endothelium selectin)
Measured: at 36 weeks
Evolution of Biological markers of endothelial dysfunction (von Willebrand factor)
Measured: at 36 weeks
Evolution of parameters of filling pressures (E-wave deceleration time).
Measured: at 36 weeks
Evolution of parameters of filling pressures (Systolic Pulmonary Artery Pressure (PAPs)).
Measured: at 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study startFeb 2027 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Nicolas GIRERD, Central Hospital, Nancy, France
- Investigators
- Nicolas GIRERD, Md PhD, Study chair, CHRU NANCY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828223
- Sponsor's protocol ID
- 2019PI092
- Other IDs
- 2024-515860-29-00
- Acronym
- KT-CANOPY
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No