Phase Ⅲ Study of Efficacy and Safety of HSK39297 Tablet in Treatment of Patients With Primary IgAN

NCT07390123 | Recruiting Phase 3

• 1 other identifier: HSK39297-303
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the efficacy and safety of HSK39297 tablets in patients with primary IgAN

Conditions

IgA Nephropathy (IgAN)

Outcome Measures

Primary Outcomes (2)

• Ratio to baseline in Urine Protein to Creatinine Ratio (sampled from 24h urine collection) at 36 weeks

  From week 1 to week 36

• Annualized total estimated Glomerular Filtration Rate slope over 48 weeks

  From week 1 to week 48

Secondary Outcomes (3)

• Annualized total estimated Glomerular Filtration Rate slope over 36 weeks

  From week 1 to week 36

• Annualized total estimated Glomerular Filtration Rate slope over 104 weeks

  From week 1 to week 104

• Incidence , severity and relationship of adverse events during the study period

  From week 1 to week 108

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

HSK39297 200mgQD

EXPERIMENTAL

Drug: HSK39297

Interventions

HSK39297 DRUG

HSK39297 200mg, once a day; treatment period; 48-weeks fixed dose.

HSK39297 200mgQD

Placebo DRUG

Placebo, once a day; treatment period; 48-weeks fixed dose.

Placebo

Eligibility Criteria

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

You may qualify if:

• Subjects must have signed and dated an IRB/IEC approved written informed consent form.Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, tumor biopsies, and other requirements of the study.
• Female and male patients above 18 years of age.
• Patients must weigh at least 35 kg to participate in the study, and must have a body mass index (BMI) below 35 kg/m2. BMI = Body weight (kg) / \[Height (m)\]2
• Subjects with a biopsy-verified IgA nephropathy and where the biopsy was performed within the prior ten years.
• h-UPCR ≥0.75g/g or 24h-UPE≥1.0g/24h at screening.
• Measured Glomerular Filtration Rate (GFR) or estimated GFR (using the CKD-EPI formula 2021) ≥30 mL/min per 1.73 m2.For patients with eGFR\* 20 to \<30ml/min/1.73m2, a qualifying biopsy performed in two years.

You may not qualify if:

• Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 90 days, whichever is longer.
• All transplanted patients (any organ, including bone marrow).
• History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer).
• Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.
• Pregnant or nursing (lactating) women.
• Plasma donation (≥ 400mL) within 12 weeks prior to first dosing.

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Weifang Zeng

CONTACT

+8602867258840; zengwf@haisco.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 5, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)