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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00773409
Recruitment Status : Completed
First Posted : October 16, 2008
Last Update Posted : September 18, 2012
Information provided by (Responsible Party):
Bracco Diagnostics, Inc

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.

Condition or disease
Renal Insufficiency

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Study Type : Observational
Actual Enrollment : 405 participants
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
Study Start Date : October 2008
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Primary Outcome Measures :
  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. [ Time Frame: 1,3,6,12,18,24 months ]

Biospecimen Retention:   Samples Without DNA
fixed tissue samples and tissue sample for testing of GBCA.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00773409

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

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Responsible Party: Bracco Diagnostics, Inc Identifier: NCT00773409     History of Changes
Other Study ID Numbers: NSF-101
First Posted: October 16, 2008    Key Record Dates
Last Update Posted: September 18, 2012
Last Verified: September 2012
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Nephrogenic Fibrosing Dermopathy
Pathologic Processes
Urologic Diseases
Skin Diseases