EUCTR2008-004496-22-FR进行中（未招募）1 期
Prospective non-randomized (pharmacoepidemiologic) cohort study (open-label, multicenter) to assess the magnitude of potential risk with the administration of Gadovist® in patients with moderate to severe renal impairment for the development of nephrogenic systemic fibrosis (NSF) based on diagnostically specific clinical and histopathologic information - Safety of Gadovist® in Renally Impaired Patients (the GRIP study)
Bayer Health Care AG (study performed by Bayer Schering Pharma AG)0 个研究点目标入组 926 人开始时间: 2009年3月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 926
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
- •Patient must be scheduled for CE-MRI with Gadovist at the recommended dose(s) in one of the approved indications (for details see Appendix 1 Patient Information Leaflet of Gadovist”)
- •Patient must fulfill criteria for moderate (eGFR 30 – 59 mL/min/1.73 m2) to severe (eGFR < 30 mL/min/1.73 m2) renal impairment.
- •Patients on chronic dialysis (both hemodialysis or peritoneal dialysis) will be automatically assigned to the severe” group and will not specifically require eGFR determination
- •Patient must sign study-specific informed consent.
- •Patients are to be imaged according to the MR imaging protocols in the participating institutions, which include that physicians are to comply with the general precaution measures of MR imaging.
- •Are the trial subjects under 18? no
- •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
- •GBCA-enhanced MRI (or administration of a GBCA for any other CE imaging procedure) within 12 months prior to administration of Gadovist
- •History of existing NSF
- •Age less than 18 years
- •Patients who are clinically unstable and whose clinical course is unpredictable
研究者
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