NCT07555054Not yet recruitingPhase 2
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
Jiangsu Hansoh Pharmaceutical Co., Ltd.1 site in 1 country182 target enrollmentStarted: May 21, 2026Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 182
- Locations
- 1
- Primary Endpoint
- Change in Urinary Albumin to Creatinine Ratio (UACR) From Baseline to Week 12
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
HS-10390 Dose B
Experimental
HS-10390 Dose B
Intervention: HS-10390 (Drug)
HS-10390 Dose C
Experimental
HS-10390 Dose C
Intervention: HS-10390 (Drug)
HS-10390 Dose A
Experimental
HS-10390 Dose A
Intervention: HS-10390 (Drug)
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.
Intervention: Irbesartan (Drug)
Outcomes
Primary Outcomes
Change in Urinary Albumin to Creatinine Ratio (UACR) From Baseline to Week 12
Time Frame: Frame: From baseline (Day 1) until Week 12 (Day 85)
Secondary Outcomes
- 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)
- 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 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))
Investigators
Study Sites (1)
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