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

Официальное название

A Phase II/III Clinical Study Evaluating the Efficacy and Safety of BAT4406F Injection in Patients With Minimal Change Disease/Focal Segmental Glomerulosclerosis

Обзор

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

Вмешательства

• Препарат BAT4406F
  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
• Другое Placebos
  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

Первичные конечные точки

• Effectiveness indicators [Срок оценки: Phase II: 26 weeks; Phase III: 52 weeks]

Вторичные конечные точки (1)

• Effectiveness indicators [Срок оценки: 26 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University First Hospital — Пекин

Идентификаторы

NCT: NCT07499700 · BAT-4406F-003-CR

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗