Renal Safety Evaluation After Dotarem®-Enhanced MRI Compared With Non-enhanced MRI in Patients at High Risk of Developing Contrast Medium Induced Nephropathy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Guerbet
- 入组人数
- 135
- 试验地点
- 15
- 主要终点
- Number of Patients Presenting Contrast-induced Nephropathy as Defined by an Increase in Serum Creatinine Levels of a Least 25% Over Baseline Levels, in the Full Analysis Set Population.
研究概览
简要总结
Although there is a well documented risk of acute renal failure with the iodinated contrast agents, the implication of intravenous gadolinium-based contrast agents in nephrotoxicity remains controversial. The aim of this study was to evaluate the safety profile of gadoterate meglumine (Dotarem®) in patients with chronic renal insufficiency by evaluating the rate of patients experiencing contrast-induced nephrotoxicity following the injection of gadoterate meglumine.
详细描述
Patients with renal insufficiency not requiring hemodialysis and scheduled to undergo a contrast enhanced MRI or unenhanced MRI examination to specify a diagnosis, were selected for inclusion. Two groups of patients were defined on the basis of the planned imaging procedure selected to obtain a diagnosis: those undergoing a Dotarem®-enhanced MRI and those undergoing an unenhanced MRI.
A clinically significant increase in serum creatinine levels after the contrast-enhanced MRI exam was used as an indication of contrast induced nephrotoxicity. A blood test was performed 24h before the MRI in order to evaluate baseline creatinine values. 72h after the exam, a second blood test was performed. An increase in creatinemia above 25% from baseline levels was defined as a contrast-induced nephrotoxic reaction. The primary endpoint of the study assessed the percentage of patients presenting a contrast-induced nephrotoxic reaction in order to show a non inferiority of enhanced as compared to non-enhanced MRI exams.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Male or female, > or equal 18 years ;
- •Patient with a known stable renal insufficiency ;
- •Patient scheduled to undergo an MRI examination to specify a diagnosis ;
- •Patient able to understand and provide written informed consent to participate in the trial ;
排除标准
- •Patient with a contra-indication to MRI ;
- •Patient who has a diagnosis of an hemodynamic instability or acute myocardial infarction within 15 days prior the inclusion ;
- •Patient who needs hemodialysis ;
- •Patient with known allergy to gadolinium chelates ;
- •Patient receiving medications known to be nephrotoxic or to cause increases in serum creatinine level within 2 weeks before the inclusion ;
- •Patients planned to either undergo surgery or receive chemotherapy ;
- •Any condition which, based on the investigator's clinical judgement, would prevent the patient from completing all trial assessments and visits ;
- •Patient under guardianship and/or inability or unwillingness to cooperate with the requirements of this trial ;
- •Patient with newly discovered unstable diabetes.
研究组 & 干预措施
Non-enhanced MRI
Patients undergoing non-enhanced MRI for diagnostic purposes
干预措施: non-enhanced MRI (Other)
Dotarem®-enhanced MRI
Patients undergoing Dotarem®-enhanced MRI for diagnostic purposes
干预措施: Dotarem®-enhanced MRI (Drug)
结局指标
主要结局
Number of Patients Presenting Contrast-induced Nephropathy as Defined by an Increase in Serum Creatinine Levels of a Least 25% Over Baseline Levels, in the Full Analysis Set Population.
时间窗: baseline pre MRI and 3 days post MRI
Comparing the number of patients experiencing an increase of creatinine of at least 25% over baseline levels after Dotarem®-enhanced MRI and after non-enhanced MRI in patients with at least a moderate renal insufficiency.
Number of Patients Presenting Contrast-induced Nephropathy as Defined by an Increase in Serum Creatinine Levels of at Least 25% Over Baseline Levels, in the Per Protocol Population.
时间窗: Baseline pre MRI and 3 days post MRI
Comparing the number of patients experiencing an increase of creatinine of at least 25% over baseline levels after Dotarem®-enhanced MRI and after non-enhanced MRI in patients with at least a moderate renal insufficiency.
次要结局
- Percent Change of Serum Creatinine Level Variation From Baseline to 72±24 Hours After Examination, in the Per Protocol Population(Baseline pre MRI and 3 days post MRI)
- Percent Change of Serum Creatinine Level From Baseline to 72±24 Hours After Examination, in the Full Analysis Set Population.(Baseline pre MRI and 3 days post MRI)
- Percent Change of Estimated Glomerular Filtration Rate (eGFR) Values From Baseline to 72±24 Hours After Examination, in the Full Analysis Set Population(Baseline pre MRI and 3 days post MRI)
- eGFR Values Variation Between Baseline and 72±24 Hours After Examination, in the Per Protocol Population(Baseline pre MRI and 3 days post MRI)