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 Injection

BRACCO IMAGING0 sites1,000 target enrollmentAugust 11, 2009

Overview

Phase: Not Applicable
Intervention: Not specified
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)
Sponsor: BRACCO IMAGING
Enrollment: 1000
Status: Active, not recruiting
Last Updated: 12 years ago

No summary available.

Registry

who.int

Start Date

August 11, 2009

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

BRACCO IMAGING

•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

•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.