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RENEW-CKD

Not yet recruitingPhase 3

Renal 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

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

NCT IDNCT07625774
Org study IDHRS-7535-307

Timeline

Milestones

Study first posted2026-06-04actual
Last update posted2026-06-04actual
Study start2026-07estimated (month precision)
Primary completion2031-05estimated (month precision)
Study completion2031-07estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Chronic kidney disease

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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

Renal / kidney
3
Cardiovascular outcomes
1
Glycemic / diabetes
1
Cardiometabolic biomarkers
1

Cardiovascular outcomes

1 endpoint
Secondary/protocol endpoint

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

time to event, event

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Time 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 endpoints
Primary/protocol endpoint

Time to first occurrence of any of the following renal composite endpoint events

Time frame:Up to approximately 4.8 years

time to event, event

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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 endpoint
Secondary/protocol endpoint

Change in systolic blood pressure from baseline at Month 9 of treatment.

Time frame:At Month 9

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.