NCT07616700RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 1 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 73 (estimated)
- First submitted
- 7 Apr 2026
- Start date
- 25 Aug 2025
- Primary completion date
- 5 Dec 2026
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Diseases
- IgA nephropathy
- NCT number
- NCT07616700
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 73
- From 25 Aug 2025 to the primary completion date, 5 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe concomitant diseases judged by the investigator to be incompatible with study participation.
- Suspected hypersensitivity to the investigational product or its class.
Other illness
- 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.
- Other conditions that may interfere with the study or increase subject risk.
Other
- Known or suspected hereditary or acquired complement deficiency.
- Active primary or secondary immunodeficiency.
- Pregnant or lactating females.
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.