NCT01467271已完成不适用
Observational Study on the Incidence of NSF in Renal Impaired Patients Following Dotarem Administration
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Guerbet
- 入组人数
- 540
- 试验地点
- 27
- 主要终点
- Number of Patients With Moderate to Severe Renal Impairment Who Develop Nephrogenic Systemic Fibrosis (NSF) After Administration of Dotarem
研究概览
简要总结
The main purpose of this study is to prospectively estimate the incidence of Nephrogenic Systemic Fibrosis (NSF) in patients with moderate to severe renal impairment after administration of Dotarem®
详细描述
All patients will be followed up during 2 years after Dotarem® administration to collect data on any suspected NSF or NSF-related symptoms
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
- •Patients with moderate to severe and end stage renal impairment or dialysis, scheduled for a contrast-enhanced Magnetic Resonance Imaging (MRI) with Dotarem
排除标准
- •Patient who has received a Gadolinium Based Contrast Agent (GBCA) within the past 12 months prior to inclusion in this study except if the GBCA received is Dotarem
结局指标
主要结局
Number of Patients With Moderate to Severe Renal Impairment Who Develop Nephrogenic Systemic Fibrosis (NSF) After Administration of Dotarem
时间窗: All patients were followed up during 2 years after Dotarem administration.
次要结局
未报告次要终点
研究者
研究点 (27)
Loading locations...
相似试验
已完成
不适用
Evaluation of the Risk of Nephrogenic Systemic Fibrosis (NSF) in Patients With Chronic Kidney Disease Without Exposure to Gadolinium Based Contrast Agents (GBCA)Renal InsufficiencyNCT00773409Bracco Diagnostics, Inc405
撤回
不适用
Evaluation of Nephrogenic Systemic Fibrosis (NSF) in Patients With Chronic Kidney Disease Following OptiMARK InjectionNephrogenic Systemic FibrosisRenal InsufficiencyNCT00811863Guerbet
Unknown
2 期
Nephrogenic Systemic Fibrosis With GadollinumNephrogenic Systemic FibrosisRenal FailureNCT01359345Imam Khomeini Hospital200
尚未招募
不适用
Circulating Factors in Nephrotic SyndromeMinimal Change DiseasePrimary Focal Segmental GlomerulosclerosisMembranous NephropathyNephrotic SyndromeNCT06315504Iain Bressendorff104
招募中
不适用
An Outcome Analysis of Primary Membranous NephropathyMembranous NephropathyNCT06242327Mario Negri Institute for Pharmacological Research500