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 Injectio

Conditions: Safety of the Contrast Enhanced Magnetic Resonance Imaging with ProHance in patients suffering from Chronic Kidney Disease (CKD) (stage 3 to 5 according to the classification of CKD by the National Kidney Foundation)stage 3 (cohort 1)stage 4-5 (cohort 2)
MedDRA version: 9.1Level: LLTClassification code 10029820Term: <Manually entered code. Term in E.1.1>
MedDRA version: 9.1Level: SOCClassification code 10038359Term: <Manually entered code. Term in E.1.1>

Registration Number: EUCTR2007-003589-16-FR

Lead Sponsor: Bracco Imaging S.p.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 1000

Inclusion Criteria

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:
COHORT 1
• 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.
COHORT 2
• 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

Exclusion Criteria

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;