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2008年9月5日
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Patients with moderate to severe renal impairment.
- 发起方
- Bayer Health Care AG
- 入组人数
- 1000
- 状态
- 进行中（未招募）
- 最后更新
- 10年前
概览
简要总结
暂无简介。
研究者
入排标准
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
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).
结局指标
主要结局
未指定
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