Chronic Kidney Disease
Conditions
Brief summary
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
Interventions
DRUGHRS-7535
HRS-7535
DRUGPlacebo
Placebo
Sponsors
Shandong Suncadia Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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; |
Secondary
| Measure | Time frame |
|---|---|
| Annual rate of change in estimated glomerular filtration rate (eGFR) from baseline to 24 Month of treatment; | From baseline to Month 24 |
| Percentage change in urine albumin-to-creatinine ratio (UACR) from baseline at Month 9 of treatment; | At Month 9 |
| Change in systolic blood pressure from baseline at Month 9 of treatment. | At Month 9 |
| Time to first diagnosis of diabetes for participants without diabetes at baseline; | 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). | Up to approximately 4.8 years |
Countries
China
Contacts
CONTACTLiang Peng
CONTACTChen Xu
Outcome results
None listed