Renal Impact of KAFTRIO in Mucoviscidose Population
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Modification of the parameters of the lithiasis assessment
研究概览
简要总结
The objective of this study is to describe the renal impact of Elexacaftor-Teacaftor-Ivacaftor, a triple modulator therapy of CFTR channel, in patients with cystic fibrosis. This new treatment acts on the CFTR channel, which is expressed at the level of the nephrons. The objective is to study the changes in plasma and urinary parameters, including metabolic explorations of urolithiasis, change in volemic parameters, renal function, urinary sediment and nutritional and glycemic parameters, in newly treated patients, through the data collected at introduction of the treatment and during the follow-up.
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
- •Patient with cystic fibrosis
- •More than 18 years old
- •Eligible for KAFTRIO
排除标准
- •KAFTRIO contraindication
- •Patient less than 18 years old
- •Dialysis patient
- •Pregnant woman
- •Greffed patient
- •Patient opposition to data collection
研究组 & 干预措施
Patient with cystic fibrosis, eligible for KAFTRIO therapy
Patient with cystic fibrosis, eligible for KATRIO, over 18 years old.
干预措施: Collection of Arterial pressure, metabolic data, kidney function, proteinuria and hematuria before and after KATRIO initiation (Drug)
Patient with cystic fibrosis, eligible for KAFTRIO therapy
Patient with cystic fibrosis, eligible for KATRIO, over 18 years old.
干预措施: Evaluation of the parameters of the lithiasis assessment before and after KAFTRIO initiation (Biological)
结局指标
主要结局
Modification of the parameters of the lithiasis assessment
时间窗: 7 months after initiation of KAFTRIO
Change in blood phosphorus and calcium metabolism ; Change in calciuria mmol/d ;Change in urinary pH, urinary specific gravity (g/mL) and crystalluria
次要结局
- Change in urinary sediment(7 month after initiation of KAFTRIO)
- Change in lung function(7 month after initiation of KAFTRIO)
- Change in volemic parameter(7 month after initiation of KAFTRIO)
- Change in renal function(7 month after initiation of KAFTRIO)
- Change in glycemic profile(7 month after initiation of KAFTRIO)