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New treatment option for Minimal Change Disease (MCD)
Official title A Clinical Study of BAT4406F Injection in Patients With Minimal Change Disease/Focal Segmental Glomerulosclerosis
ClinicalTrials.gov ID: NCT07499700
What this study is testing
What is BAT4406F?
BAT4406F is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for minimal change disease (mcd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Clinically diagnosed with NS, with a pathological diagnosis of Minimal change disease/Focal segmental glomerulosclerosis confirmed by renal biopsy...
- The time since achieving complete remission following corticosteroid therapy for the most recent active or relapsed disease is within 8 weeks of...
You likely can't join if
- Secondary Nephrotic Syndrome
- Known genetic defects associated with Nephrotic Syndrome or a family history of Nephrotic Syndrome
- 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
See the full eligibility criteria
- 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...
- The time since achieving complete remission following corticosteroid therapy for the most recent active or relapsed disease is within 8 weeks of baseline
- Secondary Nephrotic Syndrome
- Known genetic defects associated with Nephrotic Syndrome or a family history of Nephrotic Syndrome
- 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...
- 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 Human Immunodeficiency Virus or positive for Human...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.