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

Completed

• Conditions: Renal Insufficiency

• Registration Number: NCT00600951
• Lead Sponsor: Bracco Diagnostics, Inc

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

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-14
• Study First Submitted QC: 2008-01-15
• Study First Posted: 2008-01-25
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-31
• Last Update Posted: 2014-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 366

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	1, 3, 6, 12, 18 and 24 months

Trial Locations

Locations (1)

Bracco Diagnostics Inc.; 🇺🇸 Princeton, New Jersey, United States