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

NCT ID: NCT00600951

Last Updated: 2014-11-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 366 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2013-08-31

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).

Conditions

Renal Insufficiency

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

No interventions assigned to this group

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)

No interventions assigned to this group

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bracco Diagnostics, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gianpaolo Pirovano, MD

Role: STUDY_DIRECTOR

Bracco Diagnostics, Inc

Locations

Bracco Diagnostics Inc.

Princeton, New Jersey, United States

Countries

United States

Other Identifiers

MH-136

Identifier Type: -

Identifier Source: org_study_id