Evaluation of the Risk of NSF Following MultiHance Injection in Patients With Chronic Kidney Disease
Completed
Conditions studied: Renal Insufficiency
In brief
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).
Key facts
- Study ID
- NCT00600951
- Run by
- Bracco Diagnostics, Inc
- People needed
- 366
- Starts
- 2008-01-01
- Expected to finish
- 2013-08-01
- Last updated by the study team
- 2014-11-04
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Bracco Diagnostics Inc. — Princeton, New Jersey, United States
Full record on ClinicalTrials.gov
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