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
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Male or female subjects, Age ≥ 18 years at the time of signing informed consent;
2. Clinically diagnosed with chronic kidney disease at screening;
3. CKD treatment plan consistent with current clinical guidelines or local standard of care;
4. eGFR ≥ 20 mL/min/1.73 m² and UACR meeting protocol-specified criteria at screening and prior to randomization;
5. Able and willing to provide a written informed consent;
Exclusion Criteria:
1. Uncontrolled severe hypertension prior to randomization (systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 110 mmHg); or systolic blood pressure \< 90 mmHg.
2. Body mass index (BMI) \< 20 kg/m² at screening and prior to randomization.
3. Prior history of renal transplantation, or planned renal transplantation during the trial;
4. History or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2).
5. History of acute or chronic pancreatitis, pancreatic injury, acute cholecystitis, or symptomatic/treatable gallbladder disease (excluding cholecystectomy recipients);
6. Occurrence of acute kidney injury or receipt of dialysis treatment within 3 months prior to screening or randomization;
7. 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;
8. Any condition deemed inappropriate for participation in this clinical trial by the investigator.
Primary outcome measure(s)
Time to first occurrence of any of the following renal composite endpoint events — Up to approximately 4.8 years 1. Death due to renal disease;
2. Cardiovascular death;
3. Renal replacement therapy (maintenance dialysis for at least 4 weeks or renal transplantation);
4. Sustained eGFR \< 15 mL/min/1.73 m² for at least 4 weeks;
5. Sustained decline of ≥40% in eGFR from baseline for at least 4 weeks;
Trial sites (2)
Facility
City
Region
Status
Tianjin Medical University General Hospital
Tianjin
Tianjin Municipality
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
Zhejiang
More Shandong Suncadia Medicine Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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