Focal Segmental Glomerulosclerosis (FSGS), Minimal Change Disease (MCD)
Conditions
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
Interventions
DRUGBAT4406F
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
OTHERPlacebos
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
Sponsors
Bio-Thera Solutions
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Double-blind, randomized
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness indicators | Phase II: 26 weeks; Phase III: 52 weeks | Phase II: Percent change from baseline in 24-hour urinary protein at Week 26 Phase III: Time to first relapse through Week 52 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness indicators | 26 weeks | The time from randomization to the first occurrence of disease recurrence during the 26-week observation period |
Countries
China
Contacts
CONTACTmei Xiao An
PRINCIPAL_INVESTIGATORhui Ming Zhao
Peking University First Hospital
Outcome results
None listed