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
- Are there results?
- Not yet: the study is under way
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.
Show all 19Show fewer
- 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.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07828223
- Acronym / sponsor ID
- KT-CANOPY / 2019PI092
- Conditions
- Kidney Transplantation
- Keywords
- Eplérénone, Anticalcineurines, Kidney transplantation, cardiovascular
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Feb 2027 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 18 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group (under Eplerenone): | Experimental | Drug: EplerenoneStandard 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EplerenoneThe 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. | Drug | Intervention group (under Eplerenone): |
Primary outcome
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.
Time frame: at 36 weeks
19 secondary outcomes
Evolution of Nt-ProBNP concentration
Time frame: randomization, at 12 and 36 weeks
Evolution of collagen biomarkers (PICP )
Time frame: at 36 weeks
Evolution of Biological markers of endothelial dysfunction (endothelin)
Time frame: at 36 weeks
The occurrence of hyperkalaemia
Time frame: at 36 weeks
Proportion of creatinine increase > 50%
Time frame: at 36 weeks
Evolution of parameters of systolic function (LVEF, strain)
Time frame: at 36 weeks
Evolution of parameters of remodeling (left ventricular volume)
Time frame: at 36 weeks
Evolution of parameters of filling pressures (E/e')
Time frame: at 36 weeks
Evolution of peripheral systolic blood pressure (mmHg)
Time frame: at 36 weeks
Evolution of peripheral diastolic blood pressure (mmHg)
Time frame: at 36 weeks
Evolution of peripheral pulse pressure (mmHg)
Time frame: at 36 weeks
Evolution of Graft function assessed with serum creatinine (micromol/L)
Time frame: at 36 weeks
Evolution of proteinuria (mg/g)
Time frame: at 36 weeks
Evolution of parameters of remodeling (left atrial volumes)
Time frame: at 36 weeks
Evolution of collagen biomarkers ( PIIINP)
Time frame: at 36 weeks
Evolution of Biological markers of endothelial dysfunction ( soluble endothelium selectin)
Time frame: at 36 weeks
Evolution of Biological markers of endothelial dysfunction (von Willebrand factor)
Time frame: at 36 weeks
Evolution of parameters of filling pressures (E-wave deceleration time).
Time frame: at 36 weeks
Evolution of parameters of filling pressures (Systolic Pulmonary Artery Pressure (PAPs)).
Time frame: at 36 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adrien FLAHAULT, Md PhD contact
Nicolas GIRERD, Md PhD study chair
CHRU NANCY
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eplerenone in people with Kidney Transplantation, run by Central Hospital, Nancy, France at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nesrine BAILI, MD (+33 03 83 85 85 85, N.BAILI@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: at 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.