A Study to Evaluate the Long-Term Safety and Efficacy of HSK39297 Tablets in Primary IgA Nephropathy

A Multicenter, Open-Label Phase II Clinical Study to Evaluate the Long-Term Safety and Efficacy of HSK39297 Tablets in the Treatment of Primary IgA Nephropathy

This is a Phase II, multicenter, open-label study. Eligible subjects who have completed the HSK39297-202 study will be enrolled.Starting dose is 200 mg QD.Dose may be increased to 300 mg QD after 8-12 weeks of stable 200 mg QD therapy if 24-h urine protein excretion (UPE) remains >1 g/24 h and no Grade ≥3 treatment-related adverse events (AEs) occur.After the treatment period, subjects will enter the 4-week safety follow-up period.

Study Overview

• Status: Recruiting
• Conditions: IgA Nephropathy (IgAN)
• Intervention / Treatment: Drug: HSK39297 200mgQD; Drug: HSK39297 300mgQD

• Study Type: Interventional
• Enrollment (Estimated): 73
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: li fangqiong Li; Phone Number: +86028-67258840; Email: lifangq@haisco.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University First Hospital
    • Contact: Zhang hong Zhang; Phone Number: 13811123738; Email: hongzh@bjmu.edu.cn
  • Beijing, China
    • Completed
    • Peking University First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Completed the HSK39297-202 study and assessed by the investigator to have a favorable benefit-risk profile for 200 mg QD HSK39297.
2. eGFR ≥30 mL/min/1.73 m² at screening (calculated by CKD-EPI 2021 equation).
3. Able to maintain optimized, stable background therapy with RAS blockers, SGLT2 inhibitors, endothelin receptor antagonists, or hydroxychloroquine during the study.
4. Vaccinated against Neisseria meningitidis and Streptococcus pneumoniae as required in the previous study (booster if needed).

5. Fertile females: negative serum pregnancy test; highly effective contraception from signing informed consent until 30 days after last dose.

   Fertile males: highly effective contraception from signing informed consent until 90 days after last dose.

6. Voluntarily provided written informed consent and able to comply with study procedures

Exclusion Criteria:

1. Known or suspected hereditary or acquired complement deficiency.
2. Active primary or secondary immunodeficiency.
3. History of bone marrow / hematopoietic stem cell or solid organ transplantation.
4. Malignancy within the past 5 years (except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix).
5. History of recurrent invasive infections caused by encapsulated bacteria (e.g., N. meningitidis, S. pneumoniae) or Mycobacterium tuberculosis.
6. Severe concomitant diseases judged by the investigator to be incompatible with study participation.
7. Suspected hypersensitivity to the investigational product or its class.
8. Pregnant or lactating females.
9. Other conditions that may interfere with the study or increase subject risk.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Active Comparator: 200mg QD; Dose may be increased to 300 mg QD after 8-12 weeks of stable 200 mg QD therapy if 24-h urine protein excretion (UPE) remains >1 g/24 h and no Grade ≥3 treatment-related adverse events (AEs) occur.

Drug: HSK39297 200mgQD; Dose may be increased to 300 mg QD after 8-12 weeks of stable 200 mg QD therapy if 24-h urine protein excretion (UPE) remains >1 g/24 h and no Grade ≥3 treatment-related adverse events (AEs) occur.; Drug: HSK39297 300mgQD; Dose may be increased to 300 mg QD after 8-12 weeks of stable 200 mg QD therapy if 24-h urine protein excretion (UPE) remains >1 g/24 h and no Grade ≥3 treatment-related adverse events (AEs) occur.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence and severity of adverse events (AEs) during treatment.	48 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ratio of 24-h urine protein-to-creatinine ratio (24h-UPCR) from baseline every 12 weeks during treatment		48 weeks
Ratio of 24-h urine protein excretion (24h-UPE) from baseline every 12 weeks during treatment		48 weeks
Change in estimated glomerular filtration rate (eGFR) from baseline every 24 weeks during treatment.		48 weeks
Proportion of subjects with hematuria every 12 weeks during treatment.		48 weeks
Change in Functional Assessment of Chronic Illness FACIT-F(Functional Assessment of Chronic Illness Therapy-Fatigue)score from baseline every 12 weeks during treatment	The scale consists of 13 items, assessing patients' fatigue levels over the past seven days as well as fatigue impacts on cognition, physical function, psychology and social interaction. The total score is the sum of scores for all items, ranging from 0 to 52. A higher score indicates a lower degree of fatigue.	48 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic (Cmax) of HSK39297 at 300 mg QD	Exploratory Endpoint	48 weeks
Pharmacokinetic (Tmax) of HSK39297 at 300 mg QD	exploratory endpoint	48 weeks
Pharmacokinetic (AUC0-tau) of HSK39297 at 300 mg QD	exploratory endpoint	48 weeks

Collaborators and Investigators

• Sponsor: Haisco Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2025
• Primary Completion (Estimated): December 5, 2026
• Study Completion (Estimated): December 26, 2026

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Glomerulonephritis, IGA
• Other Study ID Numbers: HSK39297-204

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No