Renal Efficacy and Safety of the Novel Oral Small-Molecule GLP-1RA HRS-7535 Evaluated in Participants With Chronic Kidney Disease (RENEW-CKD)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Drug: Placebo; Drug: HRS-7535

• Study Type: Interventional
• Enrollment (Estimated): 3690
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Liang Peng; Phone Number: 0518-82342973; Email: liang.peng.lp1@hengrui.com
• Study Contact Backup: Name: Chen Xu; Phone Number: 0518-82342973; Email: chen.xu@hengrui.com

Study Locations

• China
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300052
      • Tianjin Medical University General Hospital
      • Principal Investigator: Ming Liu
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The first Affiliated Hospital, Zhejiang University School of Medicine
      • Principal Investigator: Jianghua Chen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A, Participants will receive HRS-7535 tablets administered orally	Drug: HRS-7535; HRS-7535
Placebo Comparator: Group B, Participants will receive matching placebo tablets administered orally	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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;	Up to approximately 4.8 years

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Shandong Suncadia Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): July 1, 2031

Study Registration Dates

• First Submitted: May 29, 2026
• First Submitted That Met QC Criteria: May 29, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic
• Other Study ID Numbers: HRS-7535-307

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No