A Clinical Study of BAT4406F Injection in Patients With Minimal Change Disease/Focal Segmental Glomerulosclerosis

ConditionsMinimal Change Disease (MCD)Focal Segmental Glomerulosclerosis (FSGS)

Trial statusRecruiting

Trial phasePhase 2, Phase 3

Trial typeInterventional

Biological sexAll

Age18-75

SponsorBio-Thera Solutions

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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
Placebos
Other intervention
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

Treatment groups

192 Participants

are divided into 3 treatment groups

Group A: BAT4406F Single-dose every 6 months regimen groupExperimental treatment 1 intervention

Group B: BAT4406F Double-dose every 6 months regimen groupExperimental treatment 1 intervention

Group C: BAT4406F PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

Phase II: 26 weeks; Phase III: 52 weeks

Secondary outcomes

Effectiveness indicators

The time from randomization to the first occurrence of disease recurrence during the 26-week observation period

Time frame

26 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bio-Thera Solutions

Lead sponsor

Source ClinicalTrials.gov

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