jRCT2071210119已完成不适用
A Double Blind, Randomized, Placebo-Controlled, Multicenter Phase IIa, Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab in IgA Nephropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 主要终点
- Relative change in UPCR in 24h urine
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 80age old under（—）
- 性别
- All
入选标准
- •Patients >=18 to =<80 years (at date of signing the informed consent form [ICF]), but at least of legal age in the given country
- •Biopsy confirmed diagnosis of IgAN within the past 8 years prior to signature of the ICF
- •Proteinuria at screening visit >=1.0 g/d
- •Treatment with an angiotensin-converting enzyme inhibitor (ACEi) and/or angiotensin receptor blocker (ARB) at maximum doses or maximally tolerated doses for >= 3 months prior to date of informed consent and adequate blood pressure (BP) control
- •A female of childbearing potential (FCBP), is only eligible to participate if she is not pregnant, not breast feeding, and agrees to follow the contraceptive guidance during the treatment period and for at least 3 months after the last dose of IMP
排除标准
- •Hemoglobin < 90 g/L
- •Thrombocytopenia: Platelets < 100.0 x 10^9/L.
- •Neutropenia: Neutrophils < 1.5 x 10^9/L.
- •Leukopenia: Leukocytes < 3.0 x 10^9/L
- •Diabetes mellitus type 1
- •Aspartate aminotransferase or alanine aminotransferase >1.5 x ULN, alkaline phosphatase >3.0 x ULN
结局指标
主要结局
Relative change in UPCR in 24h urine
时间窗: 9 months
Relative change in UPCR (Urine Protein to Creatinine Ratio) in 24-hour urine at 9 months compared to the reference proteinuria value in the Felzartamab dose groups vs. placebo
次要结局
未报告次要终点
研究者
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