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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

405 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Insufficiency

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gianpaolo Pirovano, MD

Role: STUDY_DIRECTOR

Bracco Diagnostics, Inc

Locations

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Bracco Diagnostics Inc.

Princeton, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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NSF-101

Identifier Type: -

Identifier Source: org_study_id