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

NCT07555054 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: HS-10390-202
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Kidney Disease

Keywords

chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• Change in Urinary Albumin to Creatinine Ratio (UACR) From Baseline to Week 12

  Frame: From baseline (Day 1) until Week 12 (Day 85)

Secondary Outcomes (6)

• 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

Study Arms (4)

HS-10390 Dose A

EXPERIMENTAL

HS-10390 Dose A

Drug: HS-10390

HS-10390 Dose B

EXPERIMENTAL

HS-10390 Dose B

Drug: HS-10390

HS-10390 Dose C

EXPERIMENTAL

HS-10390 Dose C

Drug: HS-10390

Irbesartan

ACTIVE COMPARATOR

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

Interventions

HS-10390 DRUG

HS-10390

HS-10390 Dose A

Irbesartan DRUG

Target dose of 300 mg daily

Irbesartan

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 18-70 years old;
• Body mass index (BMI) ≥18.0 and \<50.0 kg/m\^2 at screening;
• 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;
• 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;
• 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;
• Systolic BP between 90 and 160 mmHg and diastolic BP between 60 and 100 mmHg;
• Agree to contraception.

You may not qualify if:

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

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital,Sun Yat-sen University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Irbesartan

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Spiro Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Central Study Contacts

Wei Chen Professor, MD

CONTACT

13924150966; Emailwchen66@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 28, 2026
• Study Start (Estimated): May 21, 2026
• Primary Completion (Estimated): November 11, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

CN (1)