NCT07474636

Efficacy and Safety Study of HS-10542 for IgA Nephropathy

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose-Ranging Study to Evaluate the Efficacy and Safety of HS-10542 Capsules in Primary Immunoglobulin A (IgA) Nephropathy

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a Phase 2, randomized, double-blind, parallel, placebo-controlled study in patients aged 18 years or above with biopsy confirmed diagnosis of IgA nephropathy. The clinical trial is designed to test the effectiveness and safety of multiple doses of HS-10542. The main objectives is to evaluate the dose response of different doses of HS-10542 by measuring urine protein-to-creatinine ratio (UPCR). The trial is comprised of three main periods, Screening, Treatment (24 weeks) and Follow-Up (4 weeks). Approximately 90 patients will be enrolled. The findings from this study will form the basis for subsequent clinical development of HS-10542.

Conditions

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

Interventions

Type	Name	Description
DRUG	HS-10542 High Dose	Drug: HS-10542 High Dose, QD
DRUG	HS-10542 Low Dose	Drug: HS-10542 Low Dose, QD
DRUG	Placebo	Placebo, QD

Timeline

• Start date: 2026-03-17
• Primary completion: 2027-12-10
• Completion: 2028-01-30
• First posted: 2026-03-16
• Last updated: 2026-03-16

Locations

1 site across 1 country: China