NCT00600951已完成不适用
A Prospective Cohort Study Evaluating the Incidence of Nephrogenic Systemic Fibrosis in Patients With Stages 3 to 5 Chronic Kidney Disease Undergoing MRI With the Injection of MultiHance
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 366
- 试验地点
- 1
- 主要终点
- To estimate and compare the incidence of NSF in the two cohorts defined for each cohort as the number of cases of NSF observed during the follow-up time period over the total number of eligible patients.
研究概览
简要总结
The objective of this long-term study is to prospectively compare the incidence of NSF in two cohorts (Cohort 1 - patients with moderate chronic kidney disease eGFR 30 to 59 and Cohort 2 - patients with severe chronic kidney disease or kidney failure eGFR <30).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is going to receive or has received MULTIHANCE injection during an MRI examination;
- •Has CKD with eGFR stably comprised between 30 and 59 mL/min/1.73m2, as calculated from a SCr value obtained from the local laboratory within 24 hours prior to the MULTIHANCE injection.
- •Provides written informed consent and is willing to comply with protocol requirements.
- •Is going to receive or has received MULTIHANCE injection during an MRI examination;
- •Has CKD with eGFR below 30 mL/min/1.73m2, as calculated from a SCr value obtained from the local laboratory within 24 hours prior to the MULTIHANCE injection.
- •Provides written informed consent and is willing to comply with protocol requirements.
排除标准
- •Has received a GBCA within the past 12 months prior to inclusion in this study;
- •Has unstable kidney function;
- •Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data and achieving study objectives;
- •Has ever been suspected of, or diagnosed with, NSF prior to the study-specific MRI;
- •Is unable or unwilling to return for necessary office visits, to be examined by dermatologists or to undergo deep skin biopsy should development of NSF be suspected.
- •Has received a GBCA within the past 12 months prior to inclusion in this study;
- •Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data and achieving study objectives;
- •Has ever been suspected of, or diagnosed with, NSF prior to the study-specific MRI;
- •Is unable or unwilling to return for necessary office visits, to be examined by dermatologists or to undergo deep skin biopsy should development of NSF be suspected.
结局指标
主要结局
To estimate and compare the incidence of NSF in the two cohorts defined for each cohort as the number of cases of NSF observed during the follow-up time period over the total number of eligible patients.
时间窗: 1, 3, 6, 12, 18 and 24 months
次要结局
未报告次要终点
研究者
研究点 (1)
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