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

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

Study Overview

• Status: Recruiting
• Conditions: Focal Segmental Glomerulosclerosis (FSGS); Minimal Change Disease (MCD)
• Intervention / Treatment: Drug: BAT4406F; Other: Placebos

• Study Type: Interventional
• Enrollment (Estimated): 192
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: mei Xiao An; Phone Number: 8620-22233606; Email: xman@bio-thera.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Recruiting
      • Peking University First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BAT4406F Single-dose every 6 months regimen group	Drug: BAT4406F; 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
Experimental: BAT4406F Double-dose every 6 months regimen group	Drug: BAT4406F; 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
Placebo Comparator: BAT4406F Placebo	Other: Placebos; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness indicators	Phase II: Percent change from baseline in 24-hour urinary protein at Week 26 Phase III: Time to first relapse through Week 52	Phase II: 26 weeks; Phase III: 52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness indicators	The time from randomization to the first occurrence of disease recurrence during the 26-week observation period	26 weeks

Collaborators and Investigators

• Sponsor: Bio-Thera Solutions
• Investigators: Principal Investigator: hui Ming Zhao, Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2025
• Primary Completion (Estimated): October 26, 2030
• Study Completion (Estimated): November 26, 2030

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 29, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Glomerulonephritis; Nephritis; Nephrosis; Glomerulosclerosis, Focal Segmental; Nephrosis, Lipoid
• Other Study ID Numbers: BAT-4406F-003-CR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No