A Study to Evaluate the Long-Term Safety and Efficacy of HSK39297 Tablets in Primary IgA Nephropathy
Recruiting
Phase 2
Interventional Study
IgA Nephropathy (IgAN)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 73 (estimated)
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd. · Industry
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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…
Trial Locations
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Eligibility Criteria
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 ≥30 mL/min/1.73 m² at screening (calculated by CKD-EPI 2021 equation).
3. Able to maintain optimized, stable background therapy with RAS …
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