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Long-term Efficacy and Safety of FXS6837 in IgAN Patients
NCT07750665Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- Sep 2026
- Primary completion
- Nov 2029
- Countries
- 1
- Sponsor
- Fosun Pharma
- Drugs
- FXS6837
- Conditions
- IgA nephropathy (IgAN)
01
Overview
Phase 2, open-label, single-arm trial of FXS6837 in IgA nephropathy (IgAN), sponsored by Fosun Pharma. Primary endpoint: Adverse Events at 2 years. Planned start Sep 2026; status: not yet recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
experimental:FXS6837
FXS6837 Capsule
03
Who it enrols
Patients with primary IgAN who completed the FXS6837-IIb-201 study, have an eGFR >= 30 mL/min/1.73 m2, are vaccinated against N. meningitidis and S. pneumoniae, and are on stable optimized background therapy.
04
Endpoints
Primary
Adverse Events
Secondary
Urine Protein-to-Creatinine Ratio
Urine Albumin-to-Creatinine Ratio
24-hour Urine Protein Excretion
24-hour Urine Albumin Excretion
Estimated Glomerular Filtration Rate
Pharmacokinetics
Complement Alternative Pathway activity
Pharmacodynamic biomarkers
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