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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT00600951
First received: January 14, 2008
Last updated: January 9, 2014
Last verified: January 2014

January 14, 2008
January 9, 2014
January 2008
May 2014   (final data collection date for 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 ]
Same as current
Complete list of historical versions of study NCT00600951 on ClinicalTrials.gov Archive Site
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Evaluation of the Risk of NSF Following MultiHance 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 MultiHance

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).

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Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

fixed tissue samples

Non-Probability Sample

A total of 1000 patients in 2 cohorts who are going to receive or have received MULTIHANCE during an MRI examination as part of their routine clinical management. The cohorts are defined as:

COHORT 1 - 600 patients of any age, with moderate CKD (stage 3, i.e., with eGFR stably comprised between 30 and 59 mL/min/1.73m2); COHORT 2 - 400 patients of any age, with severe CKD or kidney failure (stages 4 and 5, i.e., with eGFR below 30 mL/min/1.73m2).

Renal Insufficiency
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  • 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)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1000
May 2014
May 2014   (final data collection date for primary outcome measure)

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.
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00600951
MH-136
No
Bracco Diagnostics, Inc
Bracco Diagnostics, Inc
Not Provided
Study Director: Gianpaolo Pirovano, MD Bracco Diagnostics, Inc
Bracco Diagnostics, Inc
January 2014

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