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

RecruitingPhase 2Ages any - anyAllHaisco Pharmaceutical Group Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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 โ‰ฅ3 treatment-related adverse events (AEs) occur.After the treatment period, subjects will enter the 4-week safety follow-up period.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ30 mL/min/1.73 mยฒ 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.
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What it tests

  • HSK39297 200mgQD
  • HSK39297 300mgQD
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Where

2 sites
Peking University First Hospital
Beijing, China
Peking University First Hospital
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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