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Evaluation of the Risk of NSF Following ProHance Injection in Patients With Chronic Kidney Disease
This study is currently recruiting participants.
Study NCT00600834   Information provided by Bracco Diagnostics, Inc
First Received: January 15, 2008   Last Updated: November 3, 2009   History of Changes

January 15, 2008
November 3, 2009
February 2008
March 2012   (final data collection date for primary outcome measure)
To estimate and compare the incidence of NSF in the two cohorts defined. The incidence is 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. [ Time Frame: 1, 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00600834 on ClinicalTrials.gov Archive Site
 
 
 
Evaluation of the Risk of NSF Following ProHance Injection in Patients With Chronic Kidney Disease
A Prospective Cohort Study Evaluating the Incidence of Nephrogenic Systemic Fibrosis in Patients With Stages 3 to 5 Chronic Kidney Disease Undergoing MRI With the Injection of ProHance

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).

 
 
Observational
Cohort, Prospective
Renal Insufficiency
 
  • patients with moderate CKD (stage 3, according to the classification of CKD by the National Kidney Foundation, i.e., with eGFR comprised between 30 and 59 mL/min/1.73m2)
  • patients with severe CKD or kidney failure (stages 4 and 5, according to the classification of CKD by the National Kidney Foundation, i.e., with eGFR stably below 30 mL/min/1.73m2).
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
1000
March 2013
March 2012   (final data collection date for primary outcome measure)

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.
Both
 
No
Contact: Ami Saver, BS, CNMT 609-514-2206 ami.saver@diag.bracco.com
United States
 
NCT00600834
Gianpaolo Pirovano, MD, Bracco Diagnostic Inc.
PH-106
Bracco Diagnostics, Inc
 
Study Director: Gianpaolo Pirovano, MD Bracco Diagnostics, Inc
Bracco Diagnostics, Inc
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP