NCT07502638

FXS6837 for the Treatment of IgAN Patients

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of FXS6837 in IgAN Patients

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, placebo controlled Phase IIb study to explore the efficacy and safety of FXS6837 capsules in IgAN patients. About 60 patients dignosed with primary IgAN will be enrolled and randomized to three cohorts and take different dosage of FXS6837 or placebo capsules orally according to protocol.

Detailed description

This is a multicenter, randomized, double-blind, placebo-controlled study in approximately 60 patients with primary IgA nephropathy (IgAN). Participants receiving background therapy will be randomized in a 1:1:1 ratio to receive FXS6837 capsules dose 1,dose 2, or placebo, administered orally once daily. The study aims to evaluate the efficacy and safety of FXS6837 in patients with primary IgAN and to identify the optimal clinical dose.

Conditions

• IgAN

Interventions

Type	Name	Description
DRUG	FXS6837 Dose 1	FXS6837 taken orally once a day
DRUG	FXS6837 Dose 2	FXS6837 taken orally once a day
DRUG	Placebo Capsule	Placebo taken orally once a day

Timeline

• Start date: 2026-03-31
• Primary completion: 2027-09-12
• Completion: 2027-11-14
• First posted: 2026-03-31
• Last updated: 2026-03-31

Locations

1 site across 1 country: China