Actively Recruiting
Phase IIIII Study of BAT4406F Injection for Treating Minimal Change Disease and Focal Segmental Glomerulosclerosis
Led by Bio-Thera Solutions · Updated on 2026-04-03
192
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of BAT4406F injection in adults aged 18 to 75 years diagnosed with Minimal Change Disease or Focal Segmental Glomerulosclerosis. This phase IIIII, multicenter, randomized, double-blind, placebo-controlled study aims to better understand how this treatment may impact these kidney conditions, which cause nephrotic syndrome and respond to corticosteroid therapy. Participants will be randomly assigned to receive one of three treatments a single-dose BAT4406F every six months, a double-dose BAT4406F every six months, or a placebo. In Phase II, dosing involves a single dose on Day 1 or doses on Day 1 and Day 15. In Phase III, the dosing schedule depends on Phase II results and may include doses on Day 1, Day 15, Day 182, and Day 196. All doses are administered by intravenous infusion. During the study, participants will undergo assessments to monitor kidney function, disease remission status, and safety over 26 weeks in Phase II and 52 weeks in Phase III. Researchers will measure effectiveness indicators and monitor for side effects. The study includes careful screening and follow-up visits, with the total participation lasting up to 52 weeks depending on the phase.
CONDITIONS
Brief 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 and confirmed Minimal Change Disease by kidney biopsy within 7 years or Focal Segmental Glomerulosclerosis within 10 years
- Responsive to corticosteroid therapy
- Achieved complete remission from nephrotic syndrome within 8 weeks prior to baseline
You will not qualify if you...
- Secondary nephrotic syndrome
- Known genetic causes or family history of nephrotic syndrome
- Received B-cell depletion or modifying therapy within 6 months before baseline
- History of allergy to monoclonal antibodies or allergy predisposition
- Used immunosuppressants within 60 days before baseline
- Received immunoglobulin within 90 days or immunomodulators within 4 weeks before baseline
- Participated in another investigational drug trial within 90 days or plans to during this study
- Significant liver or kidney function abnormalities
- Positive tests for hepatitis B, hepatitis C, syphilis, or HIV infection
Research Team
M
mei Xiao An
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