NCT06830629招募中2 期
An Open-Label Phase 2 Study to Evaluate the Safety, Tolerability, and Effect on Albuminuria of MZE829 in Adults With Proteinuric Chronic Kidney Disease and the APOL1 High Risk Genotype
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 74
- 试验地点
- 87
- 主要终点
- Safety and tolerability as assessed by incidence of adverse events (AEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and effect on Albuminuria of MZE829 in Adults with APOL1 Kidney Disease.
详细描述
An open-label Phase 2 study is designed to evaluate the safety, tolerability, and effect on Albuminuria of MZE829 in Adults with Proteinuric Chronic Kidney Disease and the APOL1 High Risk Genotype.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •APOL1 high risk genotype of G1/G1, G2/G2, or G1/G2
- •Chronic kidney disease with persistent albuminuria
排除标准
- •Organ or bone marrow transplantation
- •History of active cancer within past 2 years, except for treated non-melanoma skin cancer, stage 0 cervical cancer, or stage 1 prostate cancer
- •Conditions that may alter drug absorption, e.g., history of bariatric surgery
- •Type I diabetes
- •Pregnant or currently nursing
- •Other inclusion/exclusion criteria defined in protocol apply.
研究组 & 干预措施
MZE829
Experimental
Cohort 1: Chronic kidney disease with concurrent diabetes
Cohort 2: Chronic kidney disease without concurrent diabetes
干预措施: MZE829 (Drug)
结局指标
主要结局
Safety and tolerability as assessed by incidence of adverse events (AEs)
时间窗: Day 1 to Week 12
Safety and tolerability as assessed by incidence of adverse events (AEs)
时间窗: Baseline to Week 12
次要结局
- Percent participants with ≥30% reduction from baseline in UACR at Week 12(Day 1 to Week 12)
- Geometric mean plasma drug concentrations(Day 1 to Week 12)
- Percent participants with ≥30% reduction from baseline in UACR at Week 12(Baseline to Week 12)
- Geometric mean plasma drug concentrations(Baseline to Week 12)
研究者
研究点 (87)
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