Prospective Evaluation of the Incidence of NSF in Patients With Kidney Disease Undergoing MR

Completed

Conditions studied: Nephrogenic Systemic Fibrosis

In brief

Phase 4, open-label, two-year, prospective, multi-center, follow-up study conducted at up 15 sites in USA. Approximately 1,000 patients with moderate-to-severe CKD will be enrolled and followed for up to 24 months.

Key facts

Study ID

NCT01135316

Run by

Lantheus Medical Imaging

People needed

2

Starts

2009-10-01

Expected to finish

2013-09-01

Last updated by the study team

2014-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Kidney Disease with GFR < 60 mL/min./1.73 m\^2. Clinical Need to Receive an MRI with Contrast. Understand \& Sign Informed Consent.

You may not qualify if…

• History of known or suspected NSF. Has received any gadolinium based contrast agent within 12 months prior to enrollment.
• Has a clinically significant skin disorder which may interfere with detection of cutaneous NSF manifestations.
• Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data and achieving study objectives.
• Is unable or unwilling to return for necessary office visits or follow up calls, and/or to be examined by a physician or undergo deep skin biopsy should the development of NSF be suspected.

Where it is running

• Weill Cornell Medical College — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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