Renal Efficacy and Safety of the Novel Oral Small-Molecule GLP-1RA HRS-7535 Evaluated in Participants With Chronic Kidney Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HRS-7535, Placebo.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
- Drug HRS-7535
HRS-7535 - Drug Placebo
Placebo
Primary outcome measures
- Time to first occurrence of any of the following renal composite endpoint events [Time frame: Up to approximately 4.8 years]
Secondary outcome measures (5)
- Annual rate of change in estimated glomerular filtration rate (eGFR) from baseline to 24 Month of treatment; [Time frame: From baseline to Month 24]
- Percentage change in urine albumin-to-creatinine ratio (UACR) from baseline at Month 9 of treatment; [Time frame: At Month 9]
- Change in systolic blood pressure from baseline at Month 9 of treatment. [Time frame: At Month 9]
- Time to first diagnosis of diabetes for participants without diabetes at baseline; [Time frame: 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). [Time frame: Up to approximately 4.8 years]
Eligibility criteria
Inclusion criteria
- 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;
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Tianjin Medical University General Hospital — Tianjin
- The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou
Identifiers
NCT: NCT07625774 · HRS-7535-307