A Clinical Study of BAT4406F Injection in Patients With Minimal Change Disease/Focal Segmental Glomerulosclerosis

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Minimal Change Disease (MCD), Focal Segmental Glomerulosclerosis (FSGS)

In brief

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

Key facts

Study ID

NCT07499700

Run by

Bio-Thera Solutions

People needed

192

Starts

2025-10-26

Expected to finish

2030-11-26

Last updated by the study team

2026-04-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Peking University First Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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