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

The objective of this long-term study is to prospectively compare the incidence of NSF in two cohorts (Cohort 1 - patients with moderate chronic kidney disease eGFR 30 to 59 and Cohort 2 - patients with severe chronic kidney disease or kidney failure eGFR <30).

A total of 1000 patients in 2 cohorts who are going to receive or have received MULTIHANCE during an MRI examination as part of their routine clinical management. The cohorts are defined as:

COHORT 1 - 600 patients of any age, with moderate CKD (stage 3, i.e., with eGFR stably comprised between 30 and 59 mL/min/1.73m2); COHORT 2 - 400 patients of any age, with severe CKD or kidney failure (stages 4 and 5, i.e., with eGFR below 30 mL/min/1.73m2).

• 1
  Patients with moderate chronic kidney disease (stage 3, according to the classification of chronic kidney disease by the National Kidney Foundation, i.e., with eGFR comprised between 30 and 59 mL/min/1.73m2)
• 2
  Patients with severe chronic kidney disease or kidney failure (stages 4 and 5, according to the classification of chronic kidney disease by the National Kidney Foundation, i.e., with eGFR stably below 30 mL/min/1.73m2)

Inclusion Criteria:

COHORT 1

• Is going to receive or has received MULTIHANCE 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 MULTIHANCE injection.
• Provides written informed consent and is willing to comply with protocol requirements.

OR

COHORT 2

• Is going to receive or has received MULTIHANCE 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 MULTIHANCE 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.