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NCT07027774Toborzás még nem indult4. fázis

Effect of Henagliflozin on Renal Outcomes in Non-dialysis Patients With Advanced Chronic Kidney Disease : A Multicenter Prospective, Randomized Controlled Trial（HERO -aCKD）

A Multicenter, Prospective, Randomized, Controlled Study Evaluating the Progression of Renal Function in Patients With Late-Stage Chronic Kidney Disease Treated With Henagliflozin

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. jún. 18. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még

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Rövid összefoglaló (regiszter, angolul)

This is a multicenter, prospective, randomized, controlled study that will enroll approximately 429 subjects. The screening period will last 4-8 weeks. Subjects will undergo pre-screening based on eGFR and urinary albumin-to-creatinine ratio (UACR). Only non-dialysis subjects meeting the following criteria confirmed by local laboratories within 6 months prior to screening will be eligible for central laboratory screening: 10 mL/min/1.73m² ≤ eGFR < 30 mL/min/1.73m² and 150 mg/g (16.95 mg/mmol) ≤ UACR < 5000 mg/g (565 mg/mmol). Unless contraindicated due to intolerance, subjects with 20 mL/min/1.73m² ≤ eGFR < 30 mL/min/1.73m² must receive stable, maximally tolerated labeled daily doses of ACEi or ARB for at least 4 weeks prior to randomization. For subjects with 10 mL/min/1.73m² ≤ eGFR < 20 mL/min/1.73m², investigators will determine ACEi/ARB treatment based on patient condition per KDIGO guidelines. Other antihypertensive, lipid-lowering, and glucose-lowering therapies should be stabilized for approximately 4 weeks before randomization. Investigators are encouraged to maintain stability of medications known to affect serum creatinine levels during screening and approximately 2 weeks prior to any serum chemistry measurements throughout the study. Eligible subjects will be randomized in a 1:1:1 ratio to receive Henagliflozin (10 mg q.d., 5 mg q.d.) or conventional therapy. Thereafter, subjects will undergo laboratory assessments, concomitant medication review, adverse event collection, and clinical endpoint ascertainment at Week 4 (Day 30), Week 12 (Day 90), and Week 24 (Day 180), followed by every 12-week intervals. Throughout the study, all subjects will receive glycemic, blood pressure (target SBP <140 mmHg and DBP <90 mmHg), and lipid management according to current guidelines. All subjects will complete an end-of-study visit. Subjects discontinuing study drug prematurely should continue all subsequent study visits.

Állapot (regiszter)
Toborzás még nem indult
Fázis (regiszter)
4. fázis
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
429 (tervezett)
Első benyújtás
2025. jún. 10.
Kezdés
2025. júl. 10.
Elsődleges befejezés
2027. dec. 30.
Fő szponzor
First Affiliated Hospital of Wannan Medical College
NCT-szám
NCT07027774

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó · 4. fázis
  • Tervezett résztvevők: 429
  • 2025. júl. 10. és az elsődleges befejezés (2027. dec. 30.) között
  • Nincs megadott helyszín, ország nélkül
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

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Korábbi kezelés

  • Received SGLT2 inhibitor treatment within 8 weeks prior to enrollment or with a history of SGLT2 inhibitor intolerance;
  • Receiving combined therapy with an ACE inhibitor (ACEi) and an ARB, or a renin inhibitor combined with ACEi or ARB (based on self-report at screening and randomization visits);
  • On maintenance dialysis, has a functioning kidney transplant, or is a planned living donor transplant recipient (based on self-report at screening and randomization visits);
  • Received any intravenous immunosuppressive therapy within the previous 3 months; or any subject who received prednisone >45 mg/day (or equivalent dose) within the previous 3 months;
  • Known poor adherence to clinical follow-up or medication;
  • Myocardial infarction, unstable angina, or stroke within 12 weeks prior to enrollment;
  • Underwent coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) or valve repair/replacement within 12 weeks prior to enrollment, or plans to undergo any of these procedures after randomization;(13) Any disease other than kidney or cardiovascular disease (e.g., but not limited to, malignancy) that, in the investigator's clinical judgment, is associated with a life expectancy of less than 2 years;

Más betegség

  • Polycystic kidney disease, active lupus nephritis, or systemic vasculitis;(5) Symptomatic hypotension, or systolic blood pressure <90 mmHg or >180 mmHg at screening;
  • Active malignancy requiring treatment at the time of the first visit (except for successfully treated basal cell carcinoma, treated squamous cell carcinoma, or thyroid cancer);
  • Type 1 diabetes;(17) Investigator considers the patient unable to understand and/or comply with the study procedures and/or follow-up, or any condition that, in the investigator's opinion, may lead to the patient's inability to complete the study.
  • Additionally, subjects will be excluded at the randomization visit if any of the following occur:
    • Did not adhere to the run-in treatment;
    • No longer willing to be randomized and followed for at least 2 years;
    • Considered unsuitable for randomization by the local investigator; OR experienced ketoacidosis, heart attack (myocardial infarction), stroke, hospitalization for heart failure, hospitalization for urinary tract infection, or acute kidney injury during the run-in period.

Laborértékek

  • ALT or AST levels >3 times the upper limit of normal (ULN) at screening;
  • Current use or use within 12 weeks prior to enrollment of glucagon-like peptide-1 (GLP-1) receptor agonist medications (e.g., liraglutide, semaglutide, dulaglutide, etc.) or current participation in another clinical trial of glucose-lowering drugs that may affect kidney or cardiovascular outcomes;(9) Severe malnutrition (serum albumin <25 g/L) and/or severe anemia (hemoglobin <70 g/L);

Egyéb

  • Currently pregnant, breastfeeding, or a woman of childbearing potential (WOCBP) unless using a highly effective method of contraception;

Kiket keres a vizsgálat

  • The investigator considers that the participant does not require Henagliflozin or any other SGLT-2 inhibitor therapy, nor deems such therapy absolutely inappropriate; and based on local laboratory results within 6 months before the screening visit and at the screening visit, the following criteria must be met:
    • 10 mL/min/1.73m² ≤ eGFR < 30 mL/min/1.73m² (CKD-EPI equation), and
    • 150 mg/g (16.95 mg/mmol) ≤ Urine Albumin-to-Creatinine Ratio (UACR) < 5000 mg/g (565 mg/mmol)
  • Age ≥ 18 years, male or femal
  • Participants with 20 mL/min/1.73m² ≤ eGFR < 30 mL/min/1.73m² must be on a stable and tolerated dose of an ACE inhibitor (ACEI) or ARB for at least 4 weeks, unless intolerant (reasons for intolerance must be documented). Participants with 10 mL/min/1.73m² ≤ eGFR < 20 mL/min/1.73m² should have ACEI/ARB use determined by the investigator based on the patient's clinical status and KDIGO guideline recommendations;
  • Anticipated time to requiring dialysis is greater than 1 month;
  • Provision of written informed consent (illiterate participants may use a thumbprint in lieu of a signature).

Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

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