Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

14. september 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

132

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: 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.
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
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.
Tidsramme: at 36 weeks
at 36 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evolution of Nt-ProBNP concentration
Tidsramme: randomization, at 12 and 36 weeks
randomization, at 12 and 36 weeks
Evolution of collagen biomarkers (PICP )
Tidsramme: at 36 weeks
at 36 weeks
Evolution of Biological markers of endothelial dysfunction (endothelin)
Tidsramme: at 36 weeks
at 36 weeks
The occurrence of hyperkalaemia
Tidsramme: at 36 weeks
hyperkalaemia between 5 - 5.49; 5.5 - 6; >6mmol/L
at 36 weeks
Proportion of creatinine increase > 50%
Tidsramme: 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)
Tidsramme: at 36 weeks
at 36 weeks
Evolution of parameters of remodeling (left ventricular volume)
Tidsramme: at 36 weeks
at 36 weeks
Evolution of parameters of filling pressures (E/e')
Tidsramme: at 36 weeks
at 36 weeks
Evolution of peripheral systolic blood pressure (mmHg)
Tidsramme: at 36 weeks
at 36 weeks
Evolution of peripheral diastolic blood pressure (mmHg)
Tidsramme: at 36 weeks
at 36 weeks
Evolution of peripheral pulse pressure (mmHg)
Tidsramme: at 36 weeks
at 36 weeks
Evolution of Graft function assessed with serum creatinine (micromol/L)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: at 36 weeks
at 36 weeks
Evolution of collagen biomarkers ( PIIINP)
Tidsramme: at 36 weeks
at 36 weeks
Evolution of Biological markers of endothelial dysfunction ( soluble endothelium selectin)
Tidsramme: at 36 weeks
at 36 weeks
Evolution of Biological markers of endothelial dysfunction (von Willebrand factor)
Tidsramme: at 36 weeks
at 36 weeks
Evolution of parameters of filling pressures (E-wave deceleration time).
Tidsramme: at 36 weeks
at 36 weeks
Evolution of parameters of filling pressures (Systolic Pulmonary Artery Pressure (PAPs)).
Tidsramme: at 36 weeks
at 36 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Central Hospital, Nancy, France

Efterforskere

  • Studiestol: Nicolas GIRERD, Md PhD, CHRU NANCY

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. februar 2027

Primær færdiggørelse (Anslået)

1. december 2030

Studieafslutning (Anslået)

1. december 2030

Datoer for studieregistrering

Først indsendt

14. september 2026

Først indsendt, der opfyldte QC-kriterier

14. september 2026

Først opslået (Faktiske)

18. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner