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临床试验/NCT04190888
NCT04190888已完成不适用

Sickle Cell Uric Acid (SCUA) - Cohort Repository

Virginia Commonwealth University1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
78
试验地点
1
主要终点
Percentage of participants in the sample with hyperuricemia

研究概览

简要总结

The purpose of this research is to study the causes of Sickle Cell kidney disease, as well as to collect and store samples and information about people with Sickle Cell Disease.

详细描述

Sickle Cell Disease causes kidney injury over time, but it is not clear why some individuals have very significant chronic kidney disease and why some do not. The purpose of this research is to study whether having high levels of 'uric acid,' which is a naturally occurring molecule in the body that may increase kidney injury and systemic inflammation, accelerates the progression of chronic kidney disease over time. Researchers will measure the number of participants that have high uric acid levels at the beginning of the study, as well as the number of participants that develop new high levels throughout the study. The study will also try to determine what causes the high uric acid levels in some patients but not others. The results of this study could help understand kidney injury and uric acid in sickle cell disease better.

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
5 Years 至 29 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age 5-29 years
  • Sickle cell disease as diagnosed by hemoglobin electrophoresis, or by newborn screen per standard of care
  • Currently receiving comprehensive sickle cell care at the Children's Hospital of Richmond at VCU or in the adult Internal Medicine sickle cell care clinic at VCU.

排除标准

  • Those who have received organ, stem cell, or bone marrow transplantation. - Those who require chronic dialysis

结局指标

主要结局

Percentage of participants in the sample with hyperuricemia

时间窗: Baseline

(i.e. high uric acid levels) out of all patients with a uric acid level measured at baseline.

The mean rate of change of estimated glomerular filtration rate (eGFR) per year in those with hyperuricemia and those with normouricemia

时间窗: Baseline to year 5

Determine the mean rate of change of eGFR per year for each group.

Incidence rate of hyperuricemia per year

时间窗: Baseline to year 5

Calculate the incidence rate of new cases of hyperuricemia per year in each year of the cohort study

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Sickle Cell Uric Acid (SCUA) - Cohort Repository | 临床试验