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.
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).
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).
Single group
HSK39297 200mgQD
DrugDose 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.
HSK39297 300mgQD
DrugDose 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.
Incidence and severity of adverse events (AEs) during treatment.
Ratio of 24-h urine protein-to-creatinine ratio (24h-UPCR) from baseline every 12 weeks during treatment
Ratio of 24-h urine protein excretion (24h-UPE) from baseline every 12 weeks during treatment
Change in estimated glomerular filtration rate (eGFR) from baseline every 24 weeks during treatment.
Proportion of subjects with hematuria every 12 weeks during treatment.
Pharmacokinetic (Cmax) of HSK39297 at 300 mg QD
Exploratory Endpoint
Pharmacokinetic (Tmax) of HSK39297 at 300 mg QD
exploratory endpoint
Pharmacokinetic (AUC0-tau) of HSK39297 at 300 mg QD
exploratory endpoint
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