Evaluation of the Risk of NSF Following MultiHance Injection in Patients With Chronic Kidney Disease
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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) |
Outcome Measures
Primary Outcome Measures
- To estimate and compare the incidence of NSF in the two cohorts defined for each cohort as the number of cases of NSF observed during the follow-up time period over the total number of eligible patients. [1, 3, 6, 12, 18 and 24 months]
Eligibility Criteria
Criteria
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;
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bracco Diagnostics Inc. | Princeton | New Jersey | United States | 08543 |
Sponsors and Collaborators
- Bracco Diagnostics, Inc
Investigators
- Study Director: Gianpaolo Pirovano, MD, Bracco Diagnostics, Inc
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MH-136