A Clinical Study of BAT4406F Injection in Patients With Minimal Change Disease/Focal Segmental Glomerulosclerosis
A Phase II/III Clinical Study Evaluating the Efficacy and Safety of BAT4406F Injection in Patients With Minimal Change Disease/Focal Segmental Glomerulosclerosis
Bio-Thera Solutions
192 participants
Oct 26, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- 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
Exclusion Criteria9
- Secondary Nephrotic Syndrome
- Known genetic defects associated with Nephrotic Syndrome or a family history of Nephrotic Syndrome
- Receipt of any B-cell depletion or B-cell-modifying therapy within 6 months prior to baseline
- History of allergy to monoclonal antibodies; or a predisposition to allergies
- Received treatment with immunosuppressants within 60 days prior to baseline
- Received immunoglobulin within 90 days prior to baseline; or received immunomodulators such as thymosin within 4 weeks prior to baseline
- Participation in a clinical trial of another investigational drug within 90 days prior to baseline or within 5 half-lives of the drug (whichever is longer), or plans to participate in a clinical trial of another drug during the study period
- Marked abnormalities in liver or kidney function
- Positive for hepatitis B surface antigen (HBsAg); or positive for hepatitis C virus (HCV) antibodies; or positive for Treponema pallidum antibodies; or history of Human Immunodeficiency Virus or positive for Human Immunodeficiency Virus antibodies
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Interventions
100 mg/5 mL Dosage and Administration: Intravenous infusion; 500 mg per dose. Dosage Schedule: Phase II: The single-dose group received a single dose on Day 1, and the double-dose group received a single dose on Day 1 and Day 15. Phase III: The dosing regimen will be determined based on the dose selected at the conclusion of Phase II: a single dose on Day 1 and Day 182, or a single dose on Day 1, Day 15, Day 182, and Day 196
Dosage Form: Injection Strength: 5 mL/vial Dosage and Administration: Intravenous infusion; the dose for each administration is 5 vials Dosage Schedule: Phase II: Administer once on Day 1 and Day 15; Phase III: The dosing regimen will be determined based on the dose selected at the conclusion of Phase II: Administer once on Day 1 and Day 182, or administer once on Day 1, Day 15, Day 182, and Day 196
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07499700