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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAT4406F Single-dose every 6 months regimen group | Experimental |
| |
| BAT4406F Double-dose every 6 months regimen group | Experimental |
| |
| BAT4406F Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAT4406F | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Phase II: 26 weeks; Phase III: 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness indicators | The time from randomization to the first occurrence of disease recurrence during the 26-week observation period | 26 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| mei Xiao An | Contact | 8620-22233606 | xman@bio-thera.com |
| Name | Affiliation | Role |
|---|---|---|
| hui Ming Zhao | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D009402 | Nephrosis, Lipoid |
| D005923 | Glomerulosclerosis, Focal Segmental |
| ID | Term |
|---|---|
| D009401 | Nephrosis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Double-blind, randomized
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| Placebos | Other | 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 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |