"ASsociation of Proteinuria and Progression of KidneY DysfunctioN in Sickle Cell Disease"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 355
- 试验地点
- 1
- 主要终点
- Change in albumin to creatinine(ACR) and glomerular filtration rate(eGFR)
研究概览
简要总结
To describe change in ACR and eGFR during study follow-up, and assesss the association of baseline and change in ACR and eGFR, with progression of kidney failure and/or all-cause mortality.
详细描述
This is a retrospective, non-interventional, secondary use of the data coming from the single-center secondary GEN-MOD study cohort at the Henri Mondor Hospital (Creteil, France). The GEN-MOD cohort includes 355 SCD patients.
The GEN-MOD data are accessible through the center's clinical and laboratory database and will be extracted and analyzed for the purpose of this study.
The enrolment in the GEN-MOD cohort lasted from 01 December 2002 until 01 March 2014. Follow-up occurred every six months and ranged from five to seventeen years and ended on 31 December 2019. The index date (baseline) for this study is the time of inclusion of patients in GEN-MOD cohort study
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Adults aged ≥ 18 years old.
- •Confirmed diagnosis of SCD by Hb electrophoresis or high performance liquid chromatography. SCD genotypes HbSS, HbSβ0-thal.
- •Availability of ACR and eGFR baseline records.
排除标准
- •Patients enrolled in a chronic transfusion program.
- •Patients receiving hydroxyurea treatment at the time of study enrollment.
结局指标
主要结局
Change in albumin to creatinine(ACR) and glomerular filtration rate(eGFR)
时间窗: 10 years
To describe change in ACR and eGFR during study follow-up, and assesss the association of baseline and change in ACR and eGFR, with progression of kidney failure and/or all-cause mortality
次要结局
- Progression of kidney dysfunction(10 years)
- Change in ACR(10 years)