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

Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Study ID
NCT07555054
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • HS-10390 — DRUG
    HS-10390
  • HS-10390 — DRUG
    HS-10390
  • HS-10390 — DRUG
    HS-10390
  • Irbesartan — DRUG
    Target dose of 300 mg daily

Study Details

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

Key Dates

First listed
Apr 28, 2026
Start date
May 21, 2026
Status verified
Apr 2026
Primary completion
Nov 11, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
182 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HS-10390 Dose A
    HS-10390 Dose A
  • Experimental: HS-10390 Dose B
    HS-10390 Dose B
  • Experimental: HS-10390 Dose C
    HS-10390 Dose C
  • 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.

Primary Outcome Measure

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) ]

Central Contacts

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