Development of a Bayesian Estimator for Calculating Plasma Iohexol Clearance Using Limited Sample Strategy for the Evaluation of Kidney Donation Candidates.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Iohexol pharmacokinetic calculated with Bayesian estimator and with classic method
研究概览
简要总结
In kidney transplantation, donor selection is based in part on the assessment of the functional capacity of the kidneys. For this purpose, it is recommended to measure the glomerular filtration rate (GFR) by a reference technique. To estimate GFR, several approaches are possible depending on the type of measurement (urinary or plasma) and the marker (exogenous or endogenous) used. Among these methods, the measurement of inulin clearance has long been considered the reference method. The occurrence of anaphylactic reactions led to its withdrawal from the market. Iohexol, an iodinated contrast agent, has characteristics similar to inulin. It is eliminated by glomerular filtration and its biological determination is simple.
Nevertheless, the techniques currently used to calculate plasma clearance of Iohexol have been imperfectly validated and are not always easy to implement in practice. the investigators propose to develop a Bayesian estimator for estimating Iohexol clearance applied to a population of healthy subjects, representative of potential kidney donors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Affiliated or entitled to a social security scheme
- •Volunteers who has received informed information about the study and has co-signed, with the investigator, a consent to participate in the study.
- •Aged > 18 years
排除标准
- •Volunteers with a history or morbidities that would contraindicate assessment for kidney donation according to current recommendations
- •Participation in another clinical research protocol within 3 months prior to inclusion
- •Volunteers having hypersensitivity to Iohexol or one of its excipients
- •Administration of iodinated contrast media in the week prior to inclusion
- •Known history of an immediate allergic reaction or delayed skin reaction to an iodinated contrast material or any serious doubt about such a history.
- •Pregnancy or breastfeeding in progress
研究组 & 干预措施
volunteers
48 volunteers will be included according to the following demographic characteristics (corresponding to the demographic profile of kidney donors according to the national data of the Biomedicine Agency):
- aged between 20 and 35 years old: 4 women, 3 men
- aged between 35 and 50 years old: 7 women, 5 men
- aged between 50 and 65: 11 women, 8 men
- > 65 years old: 6 women, 4 men
干预措施: Iohexol (Drug)
volunteers
48 volunteers will be included according to the following demographic characteristics (corresponding to the demographic profile of kidney donors according to the national data of the Biomedicine Agency):
- aged between 20 and 35 years old: 4 women, 3 men
- aged between 35 and 50 years old: 7 women, 5 men
- aged between 50 and 65: 11 women, 8 men
- > 65 years old: 6 women, 4 men
干预措施: pharmacokinetics (Biological)
结局指标
主要结局
Iohexol pharmacokinetic calculated with Bayesian estimator and with classic method
时间窗: Hours: 0h30, 1h00, 1h30, 02h00, 03h00, 04h00, 05h00, 06h00, 09h00, 12h00 after Iohexol administration
Clearance of Iohexol calculated with Bayesian estimator (limited samples) and with classic method (rich samples).
次要结局
- Iohexol pharmacokinetic calculated with Bayesian estimator and Brochner-Mortensen method(Hours: 0h30, 1h00, 1h30, 02h00, 03h00, 04h00, 05h00, 06h00, 09h00, 12h00 after Iohexol administration)