Efficacy and Safety Study of HS-10542 for IgA Nephropathy

Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Study ID
NCT07474636
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Glomerular Disease
  • IgAN
  • Immunoglobulin A Nephropathy (IgAN)

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • HS-10542 High Dose — DRUG
    Drug: HS-10542 High Dose, QD
  • HS-10542 Low Dose — DRUG
    Drug: HS-10542 Low Dose, QD
  • Placebo — DRUG
    Placebo, QD

Study Details

This is a multicenter, randomized, double-blind, parallel, placebo-controlled study and is being conducted to evaluate the efficacy and safety of HS-10542 capsules for primary IgA nephropathy.

Key Dates

Start date
Mar 17, 2026
Status verified
Feb 2026
Primary completion
Dec 10, 2027
Completion
Jan 30, 2028

Study Design

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

Arms

  • Experimental: HS-10542 High Dose Arm
    Experimental: HS-10542 High Dose, QD
  • Experimental: HS-10542 Low Dose Arm
    Experimental: HS-10542 Low Dose, QD
  • Placebo Comparator: Placebo Arm
    Placebo Comparator: Placebo，QD

Primary Outcome Measure

Ratio to baseline in Urine Protein to Creatinine Ratio (sampled from 24h urine collection) [ Time Frame: Baseline and Week 12 ]

Central Contacts

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