NCT00811863撤回不适用
A Prospective Study for the Detection of Nephrogenic Systemic Fibrosis in Patients With Renal Impairment Undergoing Gadoversetamide-enhanced Magnetic Resonance Imaging
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Guerbet
- 试验地点
- 1
- 主要终点
- The primary outcome measure will be the diagnosis of NSF based on clinical assessments and patient telephone calls through 24 months of follow-up.
研究概览
简要总结
The objective of this study is to prospectively monitor the incidence of adverse drug reactions, specifically NSF during routine use of gadoversetamide in a large number of patients with moderate renal insufficiency (eGFR 30-59) and severe renal insufficiency or end-stage renal disease requiring dialysis (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
- •Referred for contrast-enhanced MRI using gadoversetamide;
- •Have a documented estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73 m2 within the past 6 months or ESRD requiring dialysis; and
- •Willing and able to provide written consent (themselves or by a legally authorized representative) and agree to abide by study requirements, including being seen by a dermatologist and undergoing a skin biopsy if NSF is suspected.
排除标准
- •Have experienced a previous hypersensitivity reaction to a GBCA;
- •Have pre-existing NSF or NSF-like symptoms; or
- •Have been exposed to a GBCA within 12 months prior to the index procedure; or
- •Has a medical condition or other personal situation that would prevent providing follow-up information, completing clinic visits or otherwise supplying meaningful data to meet study objectives.
结局指标
主要结局
The primary outcome measure will be the diagnosis of NSF based on clinical assessments and patient telephone calls through 24 months of follow-up.
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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