Risk of Nephrogenic Systemic Fibrosis (NSF) in Patients With Moderate Renal Insufficiency After the Administration of Magnevist

Completed

Conditions studied: Fibrosis, Kidney Failure, Renal Insufficiency

In brief

Assess potential risk for NSF in subjects with renal impairment (moderate) post magnevist injection. Subjects will be screened within 48 hours of previously scheduled MRI, those meeting the enrollment criteria will be enrolled prior to MRI and followed for 2 years post MRI with visits occuring at 1yr and 2 yr timepoints, in addition follow-up phone calls conducted at 1, 3, 6 and 18 months to assess for skin changes suggestive of NSF.

Key facts

Study ID

NCT00744939

Run by

Bayer

People needed

168

Starts

2008-11-01

Expected to finish

2013-11-01

Last updated by the study team

2014-09-22

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have moderate (eGFR 30-59 ml/min/1.73 m\^2) renal impairment and be scheduled for a contrast enhanced MRI with Magnevist Injection at the recommended dose of 0.1 mmol/kg.

You may not qualify if…

• Gadolinium Based Contrast Agent (other then Magnevist) enhanced MRI within 12 months prior to administration of Magnevist
• History of NSF
• Clinically unstable or age <2 yrs

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Chula Vista, California, United States
• Study site — Los Angeles, California, United States
• Study site — Santa Rosa, California, United States
• Study site — Pueblo, Colorado, United States
• Study site — New Haven, Connecticut, United States
• Study site — Jacksonville, Florida, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Topeka, Kansas, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Boston, Massachusetts, United States
• Study site — Boston, Massachusetts, United States
• Study site — Brooklyn, New York, United States
• Study site — New York, New York, United States
• Study site — Stony Brook, New York, United States
• Study site — Cleveland, Ohio, United States
• Study site — Danville, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Memphis, Tennessee, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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