EUCTR2008-004496-22-DE进行中（未招募）不适用
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 AG0 个研究点目标入组 1,000 人开始时间: 2008年9月5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
- •Patient must be scheduled for CE-MRI with Gadovist based on careful risk-benefit evaluation at the recommended dose(s) in one of the approved indications.
- •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 1000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1000
排除标准
- •GBCA-enhanced MRI (or administration of a GBCA for any other CE imaging procedure) other than Gadovist 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
- •Age outside the indicated age range mentioned in national labelling. (In countries where Gadovist is indicated for use in children, children are also eligible for inclusion according to national labelling).
研究者
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