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Evaluation of the Risk of Nephrogenic Systemic Fibrosis (NSF) in Patients With Chronic Kidney Disease Without Exposure to Gadolinium Based Contrast Agents (GBCA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT00773409
First received: October 15, 2008
Last updated: September 14, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition
Renal Insufficiency

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:

Drug Information available for: Gadolinium
U.S. FDA Resources

Further study details as provided by Bracco Diagnostics, Inc:

Primary Outcome Measures:
  • 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. [ Time Frame: 1,3,6,12,18,24 months ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

fixed tissue samples and tissue sample for testing of GBCA.


Enrollment: 405
Study Start Date: October 2008
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Has received a GBCA within the past 10 years prior to inclusion in this study including the administration of a GBCA for something other than an MRI (e.g., CT or DSA);
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00773409

Locations
United States, New Jersey
Bracco Diagnostics Inc.
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Bracco Diagnostics, Inc
Investigators
Study Director: Gianpaolo Pirovano, MD Bracco Diagnostics, Inc
  More Information

No publications provided

Responsible Party: Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT00773409     History of Changes
Other Study ID Numbers: NSF-101
Study First Received: October 15, 2008
Last Updated: September 14, 2012
Health Authority: United States: Institutional Review Board
Canada: Health Canada

Additional relevant MeSH terms:
Fibrosis
Kidney Diseases
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Failure, Chronic
 Nephrogenic Fibrosing Dermopathy
Pathologic Processes
Urologic Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013