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A Study to Evaluate the Long-Term Safety and Efficacy of HSK39297 Tablets in Primary IgA Nephropathy
Sponsor: Haisco Pharmaceutical Group Co., Ltd.
Summary
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.
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
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
73
Start Date
2025-08-25
Completion Date
2026-12-26
Last Updated
2026-06-01
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Locations (2)
Peking University First Hospital
Beijing, China
Peking University First Hospital
Beijing, China