NCT03774784终止不适用
A Study of the Natural History of Leukocyte Chemotactic Factor 2 Amyloidosis (ALECT2) Disease
Alnylam Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2019年1月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Time to End-Stage Renal Disease (ESRD)
研究概览
简要总结
The purpose of this study is to characterize the natural history of leukocyte chemotactic factor 2 amyloidotic (ALECT2) disease. In this observational study participants with ALECT2 disease will be enrolled. Participants, who have already reached end-stage renal disease (ESRD), will provide retrospective chart review data and biological specimens at baseline only. Other participants, in addition to retrospective chart review, will be followed prospectively.
详细描述
Refer to www.studyALECT2.com
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, age 18 years or older;
- •Renal biopsy-proven diagnosis of ALECT2;
- •For patients with kidney disease that could be due to ALECT2, a renal biopsy may be obtained to confirm ALECT2 diagnosis.
排除标准
- •There are no exclusion criteria for this observational study.
结局指标
主要结局
Time to End-Stage Renal Disease (ESRD)
时间窗: From baseline to end of study (Month 48)
Change in Estimated Glomerular Filtration Rate (eGFR) from Baseline Up to End of Study (Month 48)
时间窗: Baseline (Day 1), Months 6, 12, 18, 24, 30, 36, 42 and 48
次要结局
- Level of Leukocyte Chemotactic Factor 2 (LECT2) Messenger Ribonucleic Acid (mRNA) in Blood(Baseline (Day 1), Months 6, 12, 18, 24, 30, 36, 42 and 48)
- Level of LECT2 mRNA in Urine(Baseline (Day 1), Months 12, 24, 36 and 48)
- Level of LECT2 Protein in Blood(Baseline (Day 1), Months 6, 12, 18, 24, 30, 36, 42 and 48)
- Percentage of Participants With Proteinuria(Baseline (Day 1), Months 12, 24, 36 and 48)
- Level of LECT2 Protein in Urine(Baseline (Day 1), Months 12, 24, 36 and 48)
研究者
研究点 (1)
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