A Study of the Effect and Safety of HS-10390 in the Treatment of Participants With Chronic Kidney Disease

Официальное название

A Randomized, Multicenter, Double-blind, Parallel Active-control Study of the Efficacy and Safety of HS-10390 for the Treatment of Participants With Chronic Kidney Disease

Обзор

The purpose of the study was to evaluate the efficacy and safety of HS-10390 in participants with chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) ≥ 30 and \<90 mL/min/1.73 m\^2, and urinary albumin to creatinine ratio (UACR) ≥ 150 mg/g and \< 3000 mg/g

Вмешательства

• Препарат HS-10390
  HS-10390
• Препарат HS-10390
  HS-10390
• Препарат HS-10390
  HS-10390
• Препарат Irbesartan
  Target dose of 300 mg daily

Первичные конечные точки

• Change in Urinary Albumin to Creatinine Ratio (UACR) From Baseline to Week 12 [Срок оценки: Frame: From baseline (Day 1) until Week 12 (Day 85)]

Вторичные конечные точки (6)

• Proportion of participants achieving ≥20%, ≥30%, and ≥40% reduction in UACR from baseline at week 12 [Срок оценки: From baseline (Day 1) until Week 12 (Day 85)]
• Change in Urine Protein/Creatinine Ratio (UPCR) From Baseline at Each Visit [Срок оценки: From baseline (Day 1) at each visit]
• Change in 24 hour Urinary Protein Excretion From Baseline at Each Visit [Срок оценки: From baseline (Day 1) at Each Visit]
• Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline at Each Visit [Срок оценки: From baseline (Day 1) at Each Visit]
• Change in Office Systolic and Diastolic Blood Pressure From Baseline at Each Visit [Срок оценки: From baseline (Day 1) at Each Visit]
• Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) [Срок оценки: From screening until Follow-up visit (Day 98)]

Критерии участия

Критерии включения

• Men and women aged 18-70 years old;
• Body mass index (BMI) ≥18.0 and <50.0 kg/m\^2 at screening;
• Currently on stable dose (maximum tolerated dose and at least one-half of the maximum labeled dose) of ACEI and/or ARB therapy for at least 4 weeks and treated for at least 3 months prior to the screening visit;
• Diagnosed with chronic kidney disease, and the estimated glomerular filtration rate (eGFR) was ≥30 and <90 mL/min/1.73 m\^2 calculated using the 2021 CKD-EPI creatine formula at screening;
• Urinary albumin/creatinine ratio (UACR) was ≥300 and <3000 mg/g for at least 2 times on different days detected by the local laboratory at screening;
• Systolic BP between 90 and 160 mmHg and diastolic BP between 60 and 100 mmHg;
• Agree to contraception.

Критерии исключения

• A known or suspected allergy to the investigational medical drug or its components or excipients;
• Within 4 weeks before screening, the following drugs could not maintain the stable regimen: diabetes drugs, hypertension drugs, non-steroidal anti-inflammatory drugs;
• If glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are prescribed, the dose are unstable within 8 weeks before screening ;
• Participants with uncontrolled diabetes mellitus (HbA1c > 8%);
• Received any other study drug treatment within 30 days or 5 half-lives (whichever is longer) prior to screening;
• Polycystic kidney disease, lupus nephritis, anti-neutrophil cytoplasmic antibody (ANCA) -associated vasculitis, acute glomerulonephritis, bilateral renal artery stenosis;
• Acute kidney injury or dialysis treatment within 6 months before screening;
• Received kidney transplant, or plan to receive kidney transplant during the trial;
• Platelet< 100×10\^9/L or hemoglobin value < 90 g/L or Hematocrit value < 27% (0.27 V/V) at screening;
• Elevations of transaminases (ALT and/or AST) >3 times upper limit of normal (ULN) or total bilirubin exceeding 1.5 times the upper limit of normal at screening;
• Serum potassium >5.5 mmol/L at screening.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital,Sun Yat-sen University — Гуанчжоу

Идентификаторы

NCT: NCT07555054 · HS-10390-202

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗