Expired Study
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Princeton, New Jersey 08543


Purpose:

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 30-59 and Cohort 2- patients with severe chronic kidney disease or kidney failure eGFR <30).


Criteria:

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.


NCT ID:

NCT00600834


Primary Contact:

Study Director
Gianpaolo Pirovano, MD
Bracco Diagnostics, Inc


Backup Contact:

N/A


Location Contact:

Princeton, New Jersey 08543
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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