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Cardiac Improvement by Eplerenone Among Patients Under Cyclosporine or Tacrolimus for Kidney Transplantation. (KT-CANOPY)

14 september 2026 uppdaterad av: Pr. Nicolas GIRERD, Central Hospital, Nancy, France

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

132

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Frankrike
      • Nantes, Frankrike
        • CHU Nantes
        • Kontakt:
        • Huvudutredare:
          • Simon VILLE, MD PhD
      • Strasbourg, Frankrike
        • CHU Strasbourg - nouvel hôpital Civil
        • Kontakt:
        • Huvudutredare:
          • Nans FLORENS, MD PhD
      • Vandœuvre-lès-Nancy, Frankrike
        • CHRU Nancy - hôpital Brabois
        • Kontakt:
        • Huvudutredare:
          • Nesrine BAILI

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Intervention group (under Eplerenone):
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.
Läkemedel: Eplerenone
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.
Inget ingripande: Controle group (without eplerenone):
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
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.
Tidsram: at 36 weeks
at 36 weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Evolution of Nt-ProBNP concentration
Tidsram: randomization, at 12 and 36 weeks
randomization, at 12 and 36 weeks
Evolution of collagen biomarkers (PICP )
Tidsram: at 36 weeks
at 36 weeks
Evolution of Biological markers of endothelial dysfunction (endothelin)
Tidsram: at 36 weeks
at 36 weeks
The occurrence of hyperkalaemia
Tidsram: at 36 weeks
hyperkalaemia between 5 - 5.49; 5.5 - 6; >6mmol/L
at 36 weeks
Proportion of creatinine increase > 50%
Tidsram: at 36 weeks
Assessment of the proportion of acute kidney injury (AKI), defined as a >50% increase in serum creatinine from baseline.
at 36 weeks
Evolution of parameters of systolic function (LVEF, strain)
Tidsram: at 36 weeks
at 36 weeks
Evolution of parameters of remodeling (left ventricular volume)
Tidsram: at 36 weeks
at 36 weeks
Evolution of parameters of filling pressures (E/e')
Tidsram: at 36 weeks
at 36 weeks
Evolution of peripheral systolic blood pressure (mmHg)
Tidsram: at 36 weeks
at 36 weeks
Evolution of peripheral diastolic blood pressure (mmHg)
Tidsram: at 36 weeks
at 36 weeks
Evolution of peripheral pulse pressure (mmHg)
Tidsram: at 36 weeks
at 36 weeks
Evolution of Graft function assessed with serum creatinine (micromol/L)
Tidsram: at 36 weeks

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.
at 36 weeks
Evolution of proteinuria (mg/g)
Tidsram: at 36 weeks
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.
at 36 weeks
Evolution of parameters of remodeling (left atrial volumes)
Tidsram: at 36 weeks
at 36 weeks
Evolution of collagen biomarkers ( PIIINP)
Tidsram: at 36 weeks
at 36 weeks
Evolution of Biological markers of endothelial dysfunction ( soluble endothelium selectin)
Tidsram: at 36 weeks
at 36 weeks
Evolution of Biological markers of endothelial dysfunction (von Willebrand factor)
Tidsram: at 36 weeks
at 36 weeks
Evolution of parameters of filling pressures (E-wave deceleration time).
Tidsram: at 36 weeks
at 36 weeks
Evolution of parameters of filling pressures (Systolic Pulmonary Artery Pressure (PAPs)).
Tidsram: at 36 weeks
at 36 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Central Hospital, Nancy, France

Utredare

  • Studiestol: Nicolas GIRERD, Md PhD, CHRU NANCY

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 februari 2027

Primärt slutförande (Beräknad)

1 december 2030

Avslutad studie (Beräknad)

1 december 2030

Studieregistreringsdatum

Först inskickad

14 september 2026

Först inskickad som uppfyllde QC-kriterierna

14 september 2026

Första postat (Faktisk)

18 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2019PI092
  • 2024-515860-29-00 (Ctis)

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