Expired Study
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Princeton, New Jersey 08543


Purpose:

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).


Criteria:

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 is Available At:


Original ID:

PH-106


NCT ID:

NCT00600834


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Bracco Diagnostics, Inc


Oversight Authority:

  • United States: Food and Drug Administration
  • Canada: Health Canada


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: Pro


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

172


Enrollment Type:

Actual


Overall Contact Information

Official Name:Gianpaolo Pirovano, MD
Study Director
Bracco Diagnostics, Inc

Study Dates

Start Date:February 2008
Completion Date:May 2013
Completion Type:Actual
Primary Completion Date:May 2013
Primary Completion Type:Actual
Verification Date:October 2014
Last Changed Date:October 31, 2014
First Received Date:January 15, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure: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.
Time Frame:1, 3, 6, 12, 18 and 24 months
Safety Issues:True

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:1
Description: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)
Study Arm Type:Other
Arm Name:2
Description: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).

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Bracco Diagnostics, Inc

Samples and Retentions

Sample Retention:None Retained
Description: Fixed tissue samples
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).
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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