A PROSPECTIVE COHORT STUDY EVALUATING THE INCIDENCE OF NEPHROGENIC SYSTEMIC FIBROSIS IN PATIENTS WITH STAGES 3 TO 5 CHRONIC KIDNEY DISEASE UNDERGOING MRI WITH THE INJECTION OF PROHANCE - Evaluation of the Risk of NSF Following ProHance Injectio

Conditions: Safety of Contrast enhanced MRI diagnoses in patients suffering from some chronic kidney disease stage 3 (cohort 1) or stage 4 to 5 (cohort 2)
MedDRA version: 9.1Level: LLTClassification code 10029820
MedDRA version: 9.1Level: SOCClassification code 10038359

Registration Number: EUCTR2007-003589-16-IT

Lead Sponsor: BRACCO IMAGING

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1000

Inclusion Criteria

Provides written informed consent and is willing to comply with protocol requirements Is going to receive or has received PROHANCE injection during an MRI examination; Has CKD with eGFR stably comprised between 30 and 59 mL/min/1.73m2, (cohort 1) or below 30 mL/min/1.73m2 (cohort 2)as calculated from a SCr value obtained from the local laboratory within 24 hours prior to the PROHANCE injection (Cohort 1).
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

Has received a GBCA within the past 12 months prior to inclusion in this study; Has unstable kidney function (only for cohort 1); 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 further evaluations should development of NSF be suspected.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this long-term, study is to prospectively compare the incidence of NSF in two cohorts: Coohort 1: patients with moderate Chronic Kidney Disease (CKD stage 3) Coohort 2: patients with severe Chronic Kidney Disease (CKD stages 4 and 5);Secondary Objective: to compare,if possible, patients with CKD stage 4 with CKD at stage 5;Primary end point(s): the conclusion of the follow-up period of two years

Secondary Outcome Measures