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 sites1,000 target enrollmentNovember 26, 2009

Overview

No summary available.

Registry

who.int

Start Date

November 26, 2009

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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;