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

This study is currently recruiting participants.
Study NCT00600951.   Last updated on August 8, 2008.   Information provided by Bracco Diagnostics, Inc

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Descriptive Information Fields
Brief Title  Evaluation of the Risk of NSF Following MultiHance Injection in Patients With Chronic Kidney Disease
Official Title  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 MultiHance
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).

Detailed Description
Study Phase
Study Type  Observational
Study Design  Cohort, Prospective
Primary Outcome Measure  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. [ Time Frame: 1, 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measure 
Condition  Renal Insufficiency
Intervention 
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  1000
Start Date  January 2008
Completion Date March 2013
Eligibility 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;
  • 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.
Gender Both
Ages
Accepts Healthy Volunteers No
Contacts ††
Contact: Kathleen Bensel, BS, CNMT     609-514-2286     kathleen.bensel@diag.bracco.com    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00600951
Organization ID MH-136
Secondary IDs ††
Study Sponsor  Bracco Diagnostics, Inc
Collaborators ††
Investigators 
Study Director:     Gianpaolo Pirovano, MD     Bracco Diagnostics, Inc    
Information Provided By Bracco Diagnostics, Inc
Verification Date August 2008
First Received Date  January 14, 2008
Last Updated Date August 8, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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