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
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;
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).
Parallel
HRS-7535
DrugHRS-7535
Placebo
DrugPlacebo
Time to first occurrence of any of the following renal composite endpoint events
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;
Annual rate of change in estimated glomerular filtration rate (eGFR) from baseline to 24 Month of treatment;
Percentage change in urine albumin-to-creatinine ratio (UACR) from baseline at Month 9 of treatment;
Change in systolic blood pressure from baseline at Month 9 of treatment.
Time to first diagnosis of diabetes for participants without diabetes at baseline;
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This trial is not recruiting at the moment. You can still explore other options:
