NCT07499700招募中2 期
A Phase II/III Clinical Study Evaluating the Efficacy and Safety of BAT4406F Injection in Patients With Minimal Change Disease/Focal Segmental Glomerulosclerosis
Bio-Thera Solutions1 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2025年10月26日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Effectiveness indicators
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed with NS, with a pathological diagnosis of MCD/FSGS confirmed by renal biopsy within 7 years (MCD) or 10 years (FSGS) 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
排除标准
- •Secondary NS
- •Known genetic defects associated with NS or a family history of NS
- •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 HIV or positive for HIV antibodies
结局指标
主要结局
Effectiveness indicators
时间窗: 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
次要结局
- Effectiveness indicators(26 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
A Phase 2 Study on the Safety and Efficacy of the Anti-BAFF-R Monoclonal Antibody, ESG206, in Patients With Primary Sjogren SyndromeNCT07375524Shanghai Escugen Biotechnology Co., Ltd40
招募中
3 期
A clinical study to check efficacy and safety of Envafolimab injection in treatment of lung cancer.CTRI/2025/09/094871Glenmark Specialty SA180
招募中
2 期
To Evaluate the Efficacy and Safety of SG301 SC Injection in Systemic Lupus ErythematosusNCT07447986Hangzhou Sumgen Biotech Co., Ltd.120
招募中
2 期
A Phase II Study of CM326 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary DiseaseChronic Obstructive Pulmonary DiseaseNCT07418736CSPC ZhongQi Pharmaceutical Technology Co., Ltd.318
招募中
2 期
A Study of SHR-2173 in Participants With Systemic Lupus ErythematosusSystemic Lupus ErythematosusNCT07299422Guangdong Hengrui Pharmaceutical Co., Ltd248