FXS6837 for the Treatment of IgAN Patients

Sponsor
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Study ID
NCT07502638
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FXS6837 Dose 1 — DRUG
    FXS6837 taken orally once a day
  • FXS6837 Dose 2 — DRUG
    FXS6837 taken orally once a day
  • Placebo Capsule — DRUG
    Placebo taken orally once a day

Study Details

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.

Key Dates

Start date
Mar 31, 2026
Status verified
Mar 2026
Primary completion
Sep 12, 2027
Completion
Nov 14, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm1：FXS6837 Dose 1
    Once daily
  • Experimental: Arm2：FXS6837 Dose 2
    Once daily
  • Placebo Comparator: Arm3：Placebo
    Once daily

Primary Outcome Measure

Ratio to baseline in Urine Protein to Creatinine Ratio (sampled from 24h urine collection) at Day180 [ Time Frame: baseline and Day180 ]

Central Contacts

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