EUCTR2007-003589-16-IT进行中（未招募）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 PROHANCE - Evaluation of the Risk of NSF Following ProHance Injection
BRACCO IMAGING0 个研究点目标入组 1,000 人开始时间: 2009年8月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Provides written informed consent and is willing to comply with protocol requirements Is going to receive or has received PROHANCE injection during an MRI examination; Has CKD with eGFR stably comprised between 30 and 59 mL/min/1.73m2, (cohort 1) or below 30 mL/min/1.73m2 (cohort 2)as calculated from a SCr value obtained from the local laboratory within 24 hours prior to the PROHANCE injection (Cohort 1).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Has received a GBCA within the past 12 months prior to inclusion in this study; Has unstable kidney function (only for cohort 1); 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 further evaluations should development of NSF be suspected.
研究者
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