A Prospective Cohort Study Evaluating the Incidence of NephrogenicSystemic Fibrosis in Patients with Stages 3 to 5 Chronic Kidney DiseaseUndergoing MRI with the Injection of ProHance - Evaluation of the Incidence of NSF Following ProHance Injection

Bracco Imaging S.p.A.0 个研究点目标入组 1,000 人开始时间: 2009年11月26日最近更新: 2012年3月19日

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•Enroll the patients who are going to receive or have just received PROHANCE injection during a Magnetic Resonance Imaging examination, provide written informed consent and are willing to comply with protocol requirements if they meet the following inclusion criteria:
•Has CKD with eGFR stably comprised between 30 and 59 mL/min/1.73m2, as calculated from a Serum Creatinine (SCr) value obtained from the local laboratory within 24 hours prior to the PROHANCE injection.
•Has CKD and/or undergoing dialysis with eGFR below 30 mL/min/1.73m2, as
•calculated from a SCr value obtained from the local laboratory within 24 hours prior to the PROHANCE injection.
•Are the trial subjects under 18? yes
•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

•Any patient must be excluded from the study if:
•Has received a GBCA (Gadolinium Based Contrast Agent) within the past 12 months prior to inclusion in this study;
•Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data and achieving study objectives;
•Has ever been suspected of, or diagnosed with, NSF prior to the study-specific MRI;
•Is unable or unwilling to return for necessary office visits, to be examined by
•dermatologists or to undergo deep skin biopsy and laboratory/other diagnostic evaluations should development of NSF be suspected.
•and for the patients in cohort 1
•Has unstable kidney function;

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