Chronic Kidney DiseasePhase 3RENEW-CKDNCT07625774
Renal Efficacy and Safety of the Novel Oral Small-Molecule GLP-1RA HRS-7535 Evaluated in Participants With Chronic Kidney Disease
A Phase 3 study testing HRS-7535 in people with Chronic Kidney Disease, run by Shandong Suncadia Medicine Co., Ltd. at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- HRS-7535
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,690 participants
- Where
- 2 sitesChina
- Study dates
- Jul 2026to Jul 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Jianghua Chen
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Ming Liu
About this study
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
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
- Conditions
- Chronic Kidney Disease
- Being tested
- HRS-7535, Placebo
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-7535Drug
HRS-7535
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Group A, Participants will receive HRS-7535 tablets administered orally | Experimental | Not described Receives: Drug: HRS-7535 |
| Group B, Participants will receive matching placebo tablets administered orally | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first occurrence of any of the following renal composite endpoint events
- Death due to renal disease；
- Cardiovascular death;
- Renal replacement therapy (maintenance dialysis for at least 4 weeks or renal transplantation);
- Sustained eGFR < 15 mL/min/1.73 m² for at least 4 weeks;
- Sustained decline of ≥40% in eGFR from baseline for at least 4 weeks;
Measured: Up to approximately 4.8 years
Secondary outcomes (5)
Annual rate of change in estimated glomerular filtration rate (eGFR) from baseline to 24 Month of treatment;
Measured: From baseline to Month 24
Percentage change in urine albumin-to-creatinine ratio (UACR) from baseline at Month 9 of treatment;
Measured: At Month 9
Change in systolic blood pressure from baseline at Month 9 of treatment.
Measured: At Month 9
Time to first diagnosis of diabetes for participants without diabetes at baseline;
Measured: 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).
Measured: Up to approximately 4.8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionMay 2031 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Shandong Suncadia Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,690 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625774
- Sponsor's protocol ID
- HRS-7535-307
- Acronym
- RENEW-CKD
- Status last verified
- May 2026
- First submitted
- 29 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07625774
- Acronym / sponsor ID
- RENEW-CKD / HRS-7535-307
- Conditions
- Chronic Kidney Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,690 participants (estimated)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2026 (estimated)
- Primary completion
- May 2031 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A, Participants will receive HRS-7535 tablets administered orally | Experimental | Drug: HRS-7535 |
| Group B, Participants will receive matching placebo tablets administered orally | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-7535HRS-7535 | Drug | Group A, Participants will receive HRS-7535 tablets administered orally |
| PlaceboPlacebo | Drug | Group B, Participants will receive matching placebo tablets administered orally |
Primary outcome
Time to first occurrence of any of the following renal composite endpoint events
Time frame: 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;
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HRS-7535 in people with Chronic Kidney Disease, run by Shandong Suncadia Medicine Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liang Peng (0518-82342973, liang.peng.lp1@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first occurrence of any of the following renal composite endpoint events (time frame: Up to approximately 4.8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.