Overview

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 Criteria:

1. 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
2. The time since achieving complete remission following corticosteroid therapy for the most recent active or relapsed disease is within 8 weeks of baseline

Exclusion Criteria:

1. Secondary Nephrotic Syndrome
2. Known genetic defects associated with Nephrotic Syndrome or a family history of Nephrotic Syndrome
3. Receipt of any B-cell depletion or B-cell-modifying therapy within 6 months prior to baseline
4. History of allergy to monoclonal antibodies; or a predisposition to allergies
5. Received treatment with immunosuppressants within 60 days prior to baseline
6. Received immunoglobulin within 90 days prior to baseline; or received immunomodulators such as thymosin within 4 weeks prior to baseline
7. 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
8. Marked abnormalities in liver or kidney function
9. 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