Skip to content

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.

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515860-29-00
Acronym
2019PI092
Enrollment
132
Registered
2025-03-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

kidney transplantation

Brief summary

Hierarchized composite criterion evaluated at 36 weeks (win ratio method), including in order of priority: 1/ Death or hospitalization for heart failure or acute coronary syndrome, 2/ Variation in indexed left ventricular mass (LVMi) (with a precision of 5 g/m² allowing patients with a difference in variation LVMi between randomization and 36 weeks of less than 5 g/m² to be considered as tied), 3/Variation in indexed left atrial volume.

Detailed description

Evolution o f parameters of systolic function (LVEF, strain), remodeling (left ventricular and atrial volumes) and filling pressures (E/e', deceleration time, PAPs) at 36 weeks, Evolution of peripheral systolic blood pressure (pSBP in mmHg), peripheral diastolic blood pressure (pDBP in mmHg), peripheral pulse pressure (pPP in mmHg) at 36 weeks, Evolution of Nt-ProBNP concentration at randomisation, 12 and 36 weeks., Evolution of collagen biomarkers (PICP and PIIINP) performed at randomisation, at 12 weeks and at 36 weeks, Evolution of Biological markers of endothelial dysfunction (endothelin, soluble endothelium selectin (sE-selectin), von Willebrand factor) performed at randomization, at 12 weeks, at 36 weeks, Graft function assessed with serum creatinine (micromol/L) with estimation of glomerular filtration rate (eGFR in mL/min/1.73m2) according to the CKD-EPI formula, as well as proteinuria measured by the proteinuria/creatininuria ratio (mg/g). The percentage of patients with GFR ≥ 90, 60-89, 45-59, 30-44, 15-29, <15ml/min/1.73m2 will also be assessed, as well as the percentage of patients with proteinuria/creatininuria ratio <500; 500-1000, 1000-2000, 2000-3000, >3000mg/g at 36Weeks, The occurrence of hyperkalaemia between 5 - 5.49; 5.5 - 6; >6mmol/L during 36 weeks follow-up, The risk of acute renal failure defined by an increase in creatinine > 50% during follow-up for 36 weeks, The echocardiographic characteristics: parameters of systolic function (LVEF, strain), remodeling (ventricular and left atrial volumes), and filling pressures (E/e', deceleration time, PAPs).

Interventions

DRUGEPLERENONE

Sponsors

CHRU De Nancy
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Hierarchized composite criterion evaluated at 36 weeks (win ratio method), including in order of priority: 1/ Death or hospitalization for heart failure or acute coronary syndrome, 2/ Variation in indexed left ventricular mass (LVMi) (with a precision of 5 g/m² allowing patients with a difference in variation LVMi between randomization and 36 weeks of less than 5 g/m² to be considered as tied), 3/Variation in indexed left atrial volume.

Secondary

MeasureTime frame
Evolution o f parameters of systolic function (LVEF, strain), remodeling (left ventricular and atrial volumes) and filling pressures (E/e', deceleration time, PAPs) at 36 weeks, Evolution of peripheral systolic blood pressure (pSBP in mmHg), peripheral diastolic blood pressure (pDBP in mmHg), peripheral pulse pressure (pPP in mmHg) at 36 weeks, Evolution of Nt-ProBNP concentration at randomisation, 12 and 36 weeks., Evolution of collagen biomarkers (PICP and PIIINP) performed at randomisation, at 12 weeks and at 36 weeks, Evolution of Biological markers of endothelial dysfunction (endothelin, soluble endothelium selectin (sE-selectin), von Willebrand factor) performed at randomization, at 12 weeks, at 36 weeks, Graft function assessed with serum creatinine (micromol/L) with estimation of glomerular filtration rate (eGFR in mL/min/1.73m2) according to the CKD-EPI formula, as well as proteinuria measured by the proteinuria/creatininuria ratio (mg/g). The percentage of patients with GFR ≥

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026