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

NCT07616700 | Recruiting Phase 2

• 1 other identifier: HSK39297-204
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

IgA Nephropathy (IgAN)

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events (AEs) during treatment.

  48 weeks

Secondary Outcomes (5)

• 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

  48 weeks

Other Outcomes (3)

• Pharmacokinetic (Cmax) of HSK39297 at 300 mg QD

  48 weeks

• Pharmacokinetic (Tmax) of HSK39297 at 300 mg QD

  48 weeks

• Pharmacokinetic (AUC0-tau) of HSK39297 at 300 mg QD

  48 weeks

Study Arms (1)

200mg QD

ACTIVE COMPARATOR

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; Drug: HSK39297 300mgQD

Interventions

HSK39297 200mgQD DRUG

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.

200mg QD

HSK39297 300mgQD DRUG

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.

200mg QD

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (2)

Peking University First Hospital

Beijing, China

COMPLETED

Peking University First Hospital

Beijing, 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

li fangqiong Li

CONTACT

+86028-67258840; lifangq@haisco.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: June 1, 2026
• Study Start: August 25, 2025
• Primary Completion (Estimated): December 5, 2026
• Study Completion (Estimated): December 26, 2026
• Last Updated: June 1, 2026

Record last verified: 2026-05

Locations

CN (2)