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).

Study Overview

• Status: Completed
• Conditions: Renal Insufficiency

• Study Type: Observational
• Enrollment (Actual): 172

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Princeton, New Jersey, United States, 08543
      • Bracco Diagnostic Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A total of 1000 patients in 2 cohorts who are going to receive or have received PROHANCE 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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
1; 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)
2; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	1, 3, 6, 12, 18 and 24 months

Collaborators and Investigators

• Sponsor: Bracco Diagnostics, Inc

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (ACTUAL): May 1, 2013
• Study Completion (ACTUAL): May 1, 2013

Study Registration Dates

• First Submitted: January 15, 2008
• First Submitted That Met QC Criteria: January 15, 2008
• First Posted (ESTIMATE): January 25, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): November 4, 2014
• Last Update Submitted That Met QC Criteria: October 31, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency
• Other Study ID Numbers: PH-106