Renal Efficacy and Safety of the Novel Oral Small-Molecule GLP-1RA HRS-7535 Evaluated in Participants With Chronic Kidney Disease

Официальное название

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase III Study to Evaluate the Efficacy and Safety of HRS-7535 in Participants With Chronic Kidney Disease

Обзор

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group and event-driven phase III clinical trial. The aim of this trial is to confirm the superiority of HRS-7535 over placebo in reducing the risks of renal outcomes and cardiovascular death among participants with chronic kidney disease (CKD) on the basis of standard of care

Вмешательства

• Препарат HRS-7535
  HRS-7535
• Препарат Placebo
  Placebo

Первичные конечные точки

• Time to first occurrence of any of the following renal composite endpoint events [Срок оценки: Up to approximately 4.8 years]

Вторичные конечные точки (5)

• Annual rate of change in estimated glomerular filtration rate (eGFR) from baseline to 24 Month of treatment; [Срок оценки: From baseline to Month 24]
• Percentage change in urine albumin-to-creatinine ratio (UACR) from baseline at Month 9 of treatment; [Срок оценки: At Month 9]
• Change in systolic blood pressure from baseline at Month 9 of treatment. [Срок оценки: At Month 9]
• Time to first diagnosis of diabetes for participants without diabetes at baseline; [Срок оценки: Up to approximately 4.8 years]
• Time to first occurrence of any cardiovascular composite endpoint event (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke). [Срок оценки: Up to approximately 4.8 years]

Критерии участия

Критерии включения

• Male or female subjects, Age ≥ 18 years at the time of signing informed consent;
• Clinically diagnosed with chronic kidney disease at screening;
• CKD treatment plan consistent with current clinical guidelines or local standard of care;
• eGFR ≥ 20 mL/min/1.73 m² and UACR meeting protocol-specified criteria at screening and prior to randomization;
• Able and willing to provide a written informed consent;

Критерии исключения

• Uncontrolled severe hypertension prior to randomization (systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 110 mmHg); or systolic blood pressure < 90 mmHg.
• Body mass index (BMI) < 20 kg/m² at screening and prior to randomization.
• Prior history of renal transplantation, or planned renal transplantation during the trial;
• History or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2).
• History of acute or chronic pancreatitis, pancreatic injury, acute cholecystitis, or symptomatic/treatable gallbladder disease (excluding cholecystectomy recipients);
• Occurrence of acute kidney injury or receipt of dialysis treatment within 3 months prior to screening or randomization;
• Presence of severe gastrointestinal diseases within 3 months prior to screening or randomization, or a history of major gastrointestinal surgery affecting gastric accommodation or gastric emptying;
• Any condition deemed inappropriate for participation in this clinical trial by the investigator.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Tianjin Medical University General Hospital — Тяньцзинь
• The First Affiliated Hospital, Zhejiang University School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT07625774 · HRS-7535-307

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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