Evaluation of the Risk of Nephrogenic Systemic Fibrosis (NSF) in Patients With Chronic Kidney Disease Without Exposure to Gadolinium Based Contrast Agents (GBCA)
A Prospective Study Evaluating the Incidence of Nephrogenic Systemic Fibrosis in Patients With Stages 4 to 5 Chronic Kidney Disease Without Exposure to Gadolinium Based Contrast Agents Within the Past 10 Years
1 other identifier
observational
405
1 country
1
Brief Summary
The objective of this long term study is to prospectively evaluate the incidence of NSF in patients with severe CKD or kidney failure including patients undergoing dialysis (stages 4 and 5 i.e., with an eGFR below 30)who have not had exposure to a GBCA within 10 years prior to enrollment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2008
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 15, 2008
CompletedFirst Posted
Study publicly available on registry
October 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedSeptember 18, 2012
September 1, 2012
3.8 years
October 15, 2008
September 14, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
To estimate the incidence of NSF in patients that have not been exposed to GBCA within the last 10 years with severe CKD including those undergoing dialysis observed during the follow-up time period over the total number of eligible patients.
1,3,6,12,18,24 months
Eligibility Criteria
A total of 400 patients will be enrolled into this study based on their renal function (eGFR) and the fact that they have been GBCA free for the past 10 years.
You may qualify if:
- Has CKD with an eGFR below 30 mL/min/1.73m2 and/or undergoing dialysis as calculated from a serum creatinine (SCr) value obtained from the local laboratory within 24 hours prior to signing the informed consent;
- Provides written informed consent and is willing to comply with protocol requirements
You may not qualify if:
- 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;
- Is unable or unwilling to return for necessary office visits, to be examined by dermatologists or to undergo deep skin biopsy and laboratory/other diagnostic evaluations should development of NSF be suspected.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bracco Diagnostics Inc.
Princeton, New Jersey, 08540, United States
Biospecimen
fixed tissue samples and tissue sample for testing of GBCA.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gianpaolo Pirovano, MD
Bracco Diagnostics, Inc
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2008
First Posted
October 16, 2008
Study Start
October 1, 2008
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
September 18, 2012
Record last verified: 2012-09