Minimal Change Disease (MCD)Phase 2/3NCT07499700
A Clinical Study of BAT4406F Injection in Patients With Minimal Change Disease/Focal Segmental Glomerulosclerosis
A Phase 2/3 study testing BAT4406F in people with Minimal Change Disease (MCD) and Focal Segmental Glomerulosclerosis (FSGS), run by Bio-Thera Solutions at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Minimal Change Disease (MCD), Focal Segmental Glomerulosclerosis (FSGS)
- What is being tested?
- BAT4406F
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- 26 Oct 2025to 26 Nov 2030
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- The time since achieving complete remission following corticosteroid therapy for the most recent active or relapsed disease is within 8 weeks of baseline
Who cannot join
- 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
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- 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 Human Immunodeficiency Virus or positive for Human Immunodeficiency Virus antibodies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality
About this study
Official title: 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
- Being tested
- BAT4406F, Placebos
- Medical subject headings
- Nephrosis, Lipoid, Glomerulosclerosis, Focal Segmental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAT4406FDrug
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
PlacebosOther
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
| Study group | Role | What they receive |
|---|---|---|
| BAT4406F Single-dose every 6 months regimen group | Experimental | Not described Receives: Drug: BAT4406F |
| BAT4406F Double-dose every 6 months regimen group | Experimental | Not described Receives: Drug: BAT4406F |
| BAT4406F Placebo | Placebo comparator | Not described Receives: Other: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Phase II: 26 weeks; Phase III: 52 weeks
Secondary outcomes (1)
Effectiveness indicators
The time from randomization to the first occurrence of disease recurrence during the 26-week observation period
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start26 Oct 2025
- Primary completion26 Oct 2030 (estimated)
- Study completion26 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimal Change Disease (MCD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomized
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bio-Thera Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- hui Ming Zhao, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499700
- Sponsor's protocol ID
- BAT-4406F-003-CR
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No