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RENEW-CKD
Not yet recruitingPhase 3Renal Efficacy and Safety of the Novel Oral Small-Molecule GLP-1RA HRS-7535 Evaluated in Participants With Chronic Kidney Disease
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
Lead sponsor
Asset
KAI-7535 / HRS-7535
Oral · GLP-1 agonist
Listed sites
2
Recruiting sites
—
Enrollment
3,690
estimated
Study population
Chronic kidney disease
Key I/E criterion
•eGFR ≥20
Primary endpoint
•First occurrence of any of the following renal composite endpoint events
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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.
Endpoints (6)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Cardiovascular outcomes
1 endpointTime 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
time to event, event
Glycemic / diabetes
1 endpointTime to first diagnosis of diabetes for participants without diabetes at baseline;
Time frame:Up to approximately 4.8 years
time to event, event
Renal / kidney
3 endpointsTime to first occurrence of any of the following renal composite endpoint events
Time frame:Up to approximately 4.8 years
time to event, event
Annual rate of change in estimated glomerular filtration rate (eGFR) from baseline to 24 Month of treatment;
Time frame:From baseline to Month 24
change from baseline, improvement
Percentage change in urine albumin-to-creatinine ratio (UACR) from baseline at Month 9 of treatment;
Time frame:At Month 9
percent change from baseline, improvement
Cardiometabolic biomarkers
1 endpointChange in systolic blood pressure from baseline at Month 9 of treatment.
Time frame:At Month 9
change from baseline, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.