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

NCT07499700 | Recruiting Phase 2 DMC

• 1 other identifier: BAT-4406F-003-CR
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Minimal Change Disease (MCD); Focal Segmental Glomerulosclerosis (FSGS)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Effectiveness indicators

  26 weeks

Study Arms (3)

BAT4406F Single-dose every 6 months regimen group

EXPERIMENTAL

Drug: BAT4406F

BAT4406F Double-dose every 6 months regimen group

EXPERIMENTAL

Drug: BAT4406F

BAT4406F Placebo

PLACEBO COMPARATOR

Other: Placebos

Interventions

BAT4406F DRUG

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

BAT4406F Double-dose every 6 months regimen group; BAT4406F Single-dose every 6 months regimen group

Placebos OTHER

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

BAT4406F Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Secondary NS
• Known genetic defects associated with NS or a family history of NS
• 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 HIV or positive for HIV antibodies

Sponsors & Collaborators

• Bio-Thera Solutions: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Nephrosis, Lipoid; Glomerulosclerosis, Focal Segmental

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Glomerulonephritis; Nephritis

Study Officials

• hui Ming Zhao

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

mei Xiao An

CONTACT

8620-22233606; xman@bio-thera.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, randomized

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: October 26, 2025
• Primary Completion (Estimated): October 26, 2030
• Study Completion (Estimated): November 26, 2030
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)