A Study to Evaluate the Long-Term Safety and Efficacy of HSK39297 Tablets in Primary IgA Nephropathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HSK39297 200mgQD, HSK39297 300mgQD.
- Who it may be relevant to
- Registry conditions: IgA Nephropathy (IgAN). Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- 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.
Primary outcome measures
- Incidence and severity of adverse events (AEs) during treatment. [Time frame: 48 weeks]
Secondary outcome measures (5)
- Ratio of 24-h urine protein-to-creatinine ratio (24h-UPCR) from baseline every 12 weeks during treatment [Time frame: 48 weeks]
- Ratio of 24-h urine protein excretion (24h-UPE) from baseline every 12 weeks during treatment [Time frame: 48 weeks]
- Change in estimated glomerular filtration rate (eGFR) from baseline every 24 weeks during treatment. [Time frame: 48 weeks]
- Proportion of subjects with hematuria every 12 weeks during treatment. [Time frame: 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 [Time frame: 48 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
China · 2 centers
- Peking University First Hospital — Beijing
- Peking University First Hospital — Beijing
Identifiers
NCT: NCT07616700 · HSK39297-204