BAT4406F injection for people with Minimal Change Disease or 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

BAT4406F injections will be tested to see if they help people with Minimal Change Disease or Focal Segmental Glomerulosclerosis who recently reached remission after corticosteroid treatment.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 192 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Bio-Thera Solutions (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07499700 on ClinicalTrials.gov

What this trial studies

This is a phase II/III, randomized, double-blind, placebo-controlled, multicenter study comparing BAT4406F injection to matching placebo in patients with biopsy-confirmed Minimal Change Disease or Focal Segmental Glomerulosclerosis. Eligible participants must have a pathological diagnosis within the protocol time windows, be responsive to corticosteroids, and have achieved complete remission within 8 weeks of baseline. Participants will be randomized to receive BAT4406F or placebo and followed for efficacy and safety endpoints related to relapse and maintenance of remission. The trial excludes secondary or genetic forms of nephrotic syndrome and recent exposure to B-cell–depleting or other specified immunomodulatory therapies.

Who should consider this trial

Good fit: Ideal candidates are patients with biopsy-confirmed Minimal Change Disease (within 7 years) or Focal Segmental Glomerulosclerosis (within 10 years) who responded to corticosteroids and achieved complete remission within 8 weeks of baseline without recent B-cell–targeting or other excluded immunosuppressive treatments.

Not a fit: Patients with secondary or genetic nephrotic syndrome, a history of allergy to monoclonal antibodies, recent B-cell depletion or other recent immunosuppressive/immunoglobulin treatments, or a family history of nephrotic syndrome are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, BAT4406F could reduce relapses and prolong steroid-free remission in patients with steroid-responsive MCD or FSGS.

How similar studies have performed: B-cell–targeting therapies such as rituximab have shown benefit in steroid-dependent MCD and some FSGS cases, so the general approach has supportive evidence though BAT4406F itself is a newer agent.

Eligibility criteria

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

Where this trial is running

Beijing, Beijing Municipality

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

Study contacts

• Principal investigator: hui Ming Zhao — Peking University First Hospital
• Study coordinator: mei Xiao An

Conditions Minimal Change Disease; Focal Segmental Glomerulosclerosis