Improving Scientific Rigor of Renal Clinical Endpoints for Sickle Cell Anemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- To develop a novel SCA-specific eGFR equation and compare with existing eGFR equations validated for the general population
研究概览
简要总结
The investigators will attempt to develop a more accurate equation to estimate eGFR in pediatric and adult sickle cell patients
详细描述
200 pediatric and 200 adult SCA participants will undergo mGFR using iohexol at baseline and at one year. On the same day, participants will undergo clinical and laboratory variables important for developing an eGFR equation. From baseline data, the investigators will perform a training and validation cohort of biologically relevant predictor variables to develop a novel equation. Then the investigators will compare the novel SCA eGFR equation to the established eGFR equation. From one year data, the investigators will determine the longitudinal concordance between pediatric and adult novel and standard eGFR equations with mGFR and variables that may alter longitudinal inferences.
In a subset of 30 adult participants, the investigators will also evaluate the correlation between mGFR using iohexol and a novel measure of mGFR that is more time efficient
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 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •SCA patients (HbSS and SB0 thalassemia)
- •Age: 5.0-50.0 at enrollment
排除标准
- •Recent SCA complication associated with hospitalization (within 30 days) or ED visit (within 14 days)
- •Current AKI defined as >0.3mg/g increase in SCr from prior visit
- •Known history of anaphylaxis with contrast agent or known pregnancy
结局指标
主要结局
To develop a novel SCA-specific eGFR equation and compare with existing eGFR equations validated for the general population
时间窗: 5 years
The investigators will use biologically relevant variables to develop a new equation for eGFR in pediatric and adult sickle cell patients
次要结局
- To determine the longitudinal concordance between pediatric and adult novel and standard eGFR equations with mGFR and variables that may alter longitudinal inferences.(5 years)
- To test the correlation of the novel mGFR method using VFI FAST and iohexol mGFR.(5 years)
研究者
Jeffrey D. Lebensburger, DO
PI
University of Alabama at Birmingham