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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorHaisco Pharmaceutical Group Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • HSK39297 200mgQD
  • HSK39297 300mgQD

Treatment groups

73 Participants
are divided into 1 treatment group