A Phase II/III Clinical Study Evaluating the Efficacy and Safety of BAT4406F Injection in Patients With Minimal Change Disease/Focal Segmental Glomerulosclerosis
Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
This is a phase II/III multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of BAT4406F injection in patients with Minimal Change Disease/Focal Segmental Glomerulosclerosis
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Clinically diagnosed with NS, with a pathological diagnosis of Minimal change disease/Focal segmental glomerulosclerosis confirmed by renal biopsy within 7 years (Minimal change disease) or 10 years (Focal segmental glomerulosclerosis) prior to screening, and who are responsive to corticosteroid therapy
• The time since achieving complete remission following corticosteroid therapy for the most recent active or relapsed disease is within 8 weeks of baseline
Locations
Other Locations
China
Peking University First Hospital
RECRUITING
Beijing
Contact Information
Primary
mei Xiao An
xman@bio-thera.com
8620-22233606
Time Frame
Start Date: 2025-10-26
Estimated Completion Date: 2030-11-26
Participants
Target number of participants: 192
Treatments
Experimental: BAT4406F Single-dose every 6 months regimen group
Experimental: BAT4406F Double-dose every 6 months regimen group
Placebo_comparator: BAT4406F Placebo
Related Therapeutic Areas
Sponsors
Leads: Bio-Thera Solutions