JPRN-jRCT2071210119招募中2 期
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
Shinnosuke Mamiya0 个研究点目标入组 8 人开始时间: 2022年1月23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
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 80age old（—）
- 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
研究者
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