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RECRUITING
NCT07616700
PHASE2

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

Sponsor: Haisco Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

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

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.

Locations (2)

Peking University First Hospital

Beijing, China

Peking University First Hospital

Beijing, China