EUCTR2008-005867-33-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 Primovist/Eovist in patients with moderate to severe renal impairment for the development of nephrogenic systemic fibrosis (NSF) based on diagnostically specific clinical and histopathologic information. - Primovist/Eovist in Renally Impaired patients (the PERI study)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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 OF THE LIVER with Primovist/Eovist based on careful risk/benefit evaluation at the recommended dose 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 will initially be qualified using the simplified MDRD formula, based on a determination of serum creatinine within 6 weeks prior to the administration of Primovist/Eovist. Final patient stratification will be based on the complete MDRD formula (13) based on age, gender, ethnicity; and on serum creatinine, serum urea nitrogen, and serum albumin concentration as measured within 24h prior to Primovist/Eovist administration.
- •Patient must sign study-specific informed consent.
- •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 Primovist/Eovist within 12 months prior to administration of Primovist/Eovist
- •-Rationale for selected time window: to minimize level of confounding from prior administration of GBCA for the estimation of risk of NSF for Primovist/Eovist while at the same time avoiding the elimination of too many potential participants from the study.
- •-Exposure to GBCA within 12 months prior to administration of Primovist/Eovist will be determined at the time of the initial evaluation via history (elicited from patient) and review of patient’s medical records, if available at that time. Subsequently, a more thorough analysis of the patient’s medical records will be carried out to ascertain the accuracy of the GBCA exposure information obtained at the time of the ÌNITIAL EVALUATION
研究者
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