BAT4406F injection for people with Minimal Change Disease or Focal Segmental Glomerulosclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: xman@bio-thera.com
• Phone: 8620-22233606

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.