Actively Recruiting
A Clinical Study of BAT4406F Injection in Patients With Minimal Change Disease/Focal Segmental Glomerulosclerosis
Led by Bio-Thera Solutions · Updated on 2026-04-03
192
Participants Needed
1
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Clinical Study of BAT4406F Injection in Patients With Minimal Change Disease/Focal Segmental Glomerulosclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinically diagnosed with nephrotic syndrome, confirmed by kidney biopsy showing Minimal Change Disease within 7 years or Focal Segmental Glomerulosclerosis within 10 years before screening
- Responsive to corticosteroid therapy
- Achieved complete remission after corticosteroid treatment within 8 weeks before baseline
You will not qualify if you...
- Secondary nephrotic syndrome
- Known genetic defects causing nephrotic syndrome or family history of nephrotic syndrome
- Received B-cell depletion or modifying therapy within 6 months before baseline
- Allergy to monoclonal antibodies or predisposition to allergies
- Used immunosuppressants within 60 days before baseline
- Received immunoglobulin within 90 days or immunomodulators like thymosin within 4 weeks before baseline
- Participated in another investigational drug trial within 90 days before baseline or plans to during this study
- Significant abnormal liver or kidney function
- Positive for hepatitis B surface antigen, hepatitis C antibodies, syphilis antibodies, HIV infection or antibodies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
M
mei Xiao An
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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