Evaluation of the Risk of NSF Following ProHance Injection in Patients With Chronic Kidney Disease

Inclusion criteria

COHORT 1

• 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, as calculated from a SCr value obtained from the local laboratory within 24 hours prior to the PROHANCE injection.
• Provides written informed consent and is willing to comply with protocol requirements.

OR

COHORT 2

• Is going to receive or has received PROHANCE injection during an MRI examination;
• Has CKD 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.
• Provides written informed consent and is willing to comply with protocol requirements.

Exclusion criteria

COHORT 1

• Has received a GBCA within the past 12 months prior to inclusion in this study;
• Has unstable kidney function;
• 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 should development of NSF be suspected.

OR

COHORT 2

• Has received a GBCA 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 should development of NSF be suspected.