MultiGFR: Equivalency Study of Different Methods of Measuring Glomerular Filtration Rate
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 166
- 试验地点
- 4
- 主要终点
- Calcium EDTA and Gd-DOTA clearance for glomerular filtration rate measurement
研究概览
简要总结
The purpose of this study is to validate in comparison to a reference method (inuline) two novel non-radioactive biomarkers for glomerular filtration rate (GFR) measurement in chronic-kidney disease (CKD) patients and in healthy volunteers: Calcium-EDTA and Gd-DOTA.
详细描述
Research on estimation and measurement of renal function has been greatly stimulated by the international concept of chronic kidney disease (CKD) and its classification into stages of severity based on the level of glomerular filtration rate (GFR) (National Kidney Foundation KDOQI and ANAES in 2002, KDIGO conference in 2005), and by the development of recommendations for clinical practice according to this stages. Many efforts have focused on the validation of new formula to estimate GFR from endogenous markers. Nevertheless, the performance of these formula is limited by a large inter individual variability, that requires in many cases the use of GFR measurement using exogenous tracers (extreme anthropometric characteristics, abnormal production of endogenous tracers, potential kidney donors, dose adjustment, nephrotoxicity monitoring...). The use of GFR measurement is burdened by a lack of availability due to methodological, biological and regulatory (for radioactive tracers) constraints. That's why a need exists for new validated tracers that will be more accessible and easier to use. Moreover, there are differences between the measurement techniques: single injection of the tracer or concentration equilibrium obtained by continuous infusion; plasma or urinary clearance.
Two new tracers for GFR measurement are here offered for validation: Gd-DOTA and Calcium-EDTA. Gd-DOTA is a macrocyclic paramagnetic contrast product, which can be measured using an ELISA type immunoassay. Although being widely used in radiology with higher doses than those that will be used for GFR measurement in the multi-GFR study, Gd-DOTA has never been involved in systemic nephrogenic fibrosis cases (ProFinest study). Calcium-EDTA has been used for many years for the chelation of heavy metals. Recently, a colorimetric assay for Calcium-EDTA measurement has been developed. Gd-DOTA and Calcium-EDTA clearance for GFR measurement will be compared to inuline clearance in healthy volunteers (25 for each new tracer) and CKD patients (150 for each new tracer).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •males or females without pregnancy
- •age : 18-75
- •stable chronic kidney disease stages 1 to 4 (MDRD KDIGO 2005), estimated GFR > 15 mL/min/1.73m²
- •clinical GFR measurement indication
排除标准
- •kidney transplantation
- •acute disease leading to acute change in GFR
- •heavy metals poisoning (treated or not)
- •gadolinium contrast agent in the previous month
- •Healthy volunteers :
- •Inclusion criteria
- •males, 18-35 years old
- •weight : 60-100 kg , BMI 18-27 kg/m²
- •estimated GFR > 90 mL/min/1.73 m² (MDRD)
- •acute diseases in the previous 7 days
- •Exclusion criteria :
- •uro-nephrological disease (past or present)
- •nephrotoxic drug chronic use in the previous 2 months
- •systemic disease (acute or chronic)
研究组 & 干预措施
Inuline - Calcium EDTA
Calcium EDTA clearance for GFR measurement is compared to inuline clearance in healthy volunteers and CKD patients (stage 1 to 4).
干预措施: Calcium EDTA (Drug)
Inuline - Gd-DOTA
Gd-DOTA clearance for GFR measurement is compared to inuline clearance in healthy volunteers and CKD patients (stage 1 to 4).
干预措施: Gd-DOTA (Drug)
结局指标
主要结局
Calcium EDTA and Gd-DOTA clearance for glomerular filtration rate measurement
时间窗: 1 day
Calcium EDTA or Gd-DOTA clearance for GFR measurement is compared to inuline clearance in healthy volunteers (n= 25) and in CKD patients (n= 150, stages 1 to 4, 30 patients for each stage) at equilibrium by measuring urinary clearances of inuline and Calcium EDTA or Gd-DOTA continuously co-infused after a loading dose.
次要结局
- Volumes of distribution of Calcium EDTA and Gd-DOTA(1 day)
- Calcium EDTA and Gd-DOTA clearance for glomerular filtration rate measurement in each CKD stage(1 day)
- Calcium EDTA and Gd-DOTA clearance reproducibility for GFR measurement(15 days)
- Calcium EDTA and Gd-DOTA clearance with single injection for GFR measurement(15 days)
- Number of participants with adverse events as a measure of safety.(45 days)