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

NCT00600834 | Completed

• 1 other identifier: PH-106
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 1

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 30-59 and Cohort 2- patients with severe chronic kidney disease or kidney failure eGFR \<30).

Conditions

Renal Insufficiency

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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).

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.
• 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.

You may not qualify if:

• COHORT 1
• 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.
• COHORT 2
• 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.

Sponsors & Collaborators

• Bracco Diagnostics, Inc: lead

Study Sites (1)

Bracco Diagnostic Inc.

Princeton, New Jersey, 08543, United States

Location

Biospecimen

Retention: NONE RETAINED

Fixed tissue samples

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Gianpaolo Pirovano, MD

  Bracco Diagnostics, Inc

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2008
• First Posted: January 25, 2008
• Study Start: February 1, 2008
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: November 4, 2014

Record last verified: 2014-10

Locations

US (1)