Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of WAL0921 in Patients With Glomerular Kidney Diseases and Proteinuria
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 64
- 主要终点
- Incidence of treatment emergent adverse events
研究概览
简要总结
This is an adaptive prospective, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of WAL0921 in subjects with glomerular kidney disease and proteinuria, including diabetic nephropathy and rare glomerular kidney diseases (primary focal segmental glomerulosclerosis [FSGS], treatment-resistant minimal change disease [TR MCD], primary immunoglobulin A nephropathy [IgAN], and primary membranous nephropathy [PMN]). Subjects in this study will be randomized to receive the investigational drug WAL0921 or placebo as an intravenous infusion once every 2 weeks for 7 total infusions. All subjects will be followed for 24 weeks after their last infusion.
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
- Double (Participant, 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
- •Adults, age 18-75 years
- •Diagnosis of one of the following glomerular kidney diseases: diabetic nephropathy; primary focal segmental glomerulosclerosis; treatment resistant-minimal change disease; primary IgA nephropathy; primary membranous nephropathy
- •eGFR greater than or equal to 30 mL/min/1.73 m2
排除标准
- •Currently pregnant or planning to become pregnant
- •History of organ transplantation
- •History of alcohol or substance use disorder
- •Acute dialysis or acute kidney injury within 6 months of Screening
- •Any prior or current medical condition that, in the judgment of the Investigator, would prevent the subject from safely participating in and/or completing all study requirements
研究组 & 干预措施
WAL0921
Intravenous infusion of investigational drug WAL0921
干预措施: WAL0921 (Drug)
Placebo
Intravenous infusion of normal saline
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of treatment emergent adverse events
时间窗: Baseline to Week 36
次要结局
- Change in albuminuria(Baseline up to Week 24)
- Change in proteinuria(Baseline up to Week 24)
- Change in estimated glomerular filtration rate(Baseline up to Week 24)
- Change in rate of change in eGFR(Baseline up to Week 24)