A Study of the Effect and Safety of HS-10390 in the Treatment of Participants With Chronic Kidney Disease

A Randomized, Multicenter, Double-blind, Parallel Active-control Study of the Efficacy and Safety of HS-10390 for the Treatment of Participants With Chronic Kidney Disease

The purpose of the study was to evaluate the efficacy and safety of HS-10390 in participants with chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) ≥ 30 and <90 mL/min/1.73 m^2, and urinary albumin to creatinine ratio (UACR) ≥ 150 mg/g and < 3000 mg/g

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Drug: HS-10390; Drug: Irbesartan

• Study Type: Interventional
• Enrollment (Estimated): 182
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Wei Chen Professor, MD; Phone Number: 13924150966; Email: Emailwchen66@qq.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital,Sun Yat-Sen University
      • Contact: Wei Chen WC archiater, Doctor; Phone Number: 13924150966; Email: Emailwchen66@qq.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Men and women aged 18-70 years old;
2. Body mass index (BMI) ≥18.0 and <50.0 kg/m^2 at screening;
3. Currently on stable dose (maximum tolerated dose and at least one-half of the maximum labeled dose) of ACEI and/or ARB therapy for at least 4 weeks and treated for at least 3 months prior to the screening visit;
4. Diagnosed with chronic kidney disease, and the estimated glomerular filtration rate (eGFR) was ≥30 and <90 mL/min/1.73 m^2 calculated using the 2021 CKD-EPI creatine formula at screening;
5. Urinary albumin/creatinine ratio (UACR) was ≥300 and <3000 mg/g for at least 2 times on different days detected by the local laboratory at screening;
6. Systolic BP between 90 and 160 mmHg and diastolic BP between 60 and 100 mmHg;
7. Agree to contraception.

Exclusion Criteria:

1. A known or suspected allergy to the investigational medical drug or its components or excipients;
2. Within 4 weeks before screening, the following drugs could not maintain the stable regimen: diabetes drugs, hypertension drugs, non-steroidal anti-inflammatory drugs;
3. If glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are prescribed, the dose are unstable within 8 weeks before screening ;
4. Participants with uncontrolled diabetes mellitus (HbA1c > 8%);
5. Received any other study drug treatment within 30 days or 5 half-lives (whichever is longer) prior to screening;
6. Polycystic kidney disease, lupus nephritis, anti-neutrophil cytoplasmic antibody (ANCA) -associated vasculitis, acute glomerulonephritis, bilateral renal artery stenosis;
7. Acute kidney injury or dialysis treatment within 6 months before screening;
8. Received kidney transplant, or plan to receive kidney transplant during the trial;
9. Platelet< 100×10^9/L or hemoglobin value < 90 g/L or Hematocrit value < 27% (0.27 V/V) at screening;
10. Elevations of transaminases (ALT and/or AST) >3 times upper limit of normal (ULN) or total bilirubin exceeding 1.5 times the upper limit of normal at screening;
11. Serum potassium >5.5 mmol/L at screening.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HS-10390 Dose A	Drug: HS-10390; HS-10390
Experimental: HS-10390 Dose B	Drug: HS-10390; HS-10390
Experimental: HS-10390 Dose C	Drug: HS-10390; HS-10390
Active Comparator: Irbesartan; Irbesartan will be administered daily as a 150-mg oral tablet. Irbesartan will be administered daily as a 150-mg orally for the first 2 weeks of the study following randomization. For patients who tolerate the initial dose of 150 mg after 2 weeks will increase their dose to 300 mg.	Drug: Irbesartan; Target dose of 300 mg daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Urinary Albumin to Creatinine Ratio (UACR) From Baseline to Week 12	Frame: From baseline (Day 1) until Week 12 (Day 85)

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants achieving ≥20%, ≥30%, and ≥40% reduction in UACR from baseline at week 12	From baseline (Day 1) until Week 12 (Day 85)
Change in Urine Protein/Creatinine Ratio (UPCR) From Baseline at Each Visit	From baseline (Day 1) at each visit
Change in 24 hour Urinary Protein Excretion From Baseline at Each Visit	From baseline (Day 1) at Each Visit
Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline at Each Visit	From baseline (Day 1) at Each Visit
Change in Office Systolic and Diastolic Blood Pressure From Baseline at Each Visit	From baseline (Day 1) at Each Visit
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)	From screening until Follow-up visit (Day 98)

Collaborators and Investigators

• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): May 21, 2026
• Primary Completion (Estimated): November 11, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 28, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: chronic kidney disease
• 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; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Polycyclic Compounds; Benzene Derivatives; Tetrazoles; Biphenyl Compounds; Spiro Compounds; Irbesartan
• Other Study ID Numbers: HS-10390-202

Drug and device information, study documents

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