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LMI - Ablavar - 401 - Study of Incidence of Nephrogenic Systemic Fibrosis(NSF) in Kidney Disease Patients Undergoing MRI With Ablavar

2014-08-27 03:13:15 | BioPortfolio

Summary

Study Design:

In this phase 4 study, all patients will receive 1 dose of Ablavar as part of an MRI examination in their routine clinical management.

A standardized NSF questionnaire will be administered to the patient at various time points post-dose. At 1 year and 2 years (+1 or -1 month) patients will return to the clinic for a limited examination for skin abnormalities and formal review of signs and symptoms suggestive of NSF.

Description

Study Design:

This Phase 4, open-label, two-year, prospective, multi-center, follow-up study will be conducted in up to 15 active sites in the United States.

All patients will receive 1 dose of Ablavar as part of an MRI examination in their routine clinical management. Prior to undergoing an Ablavar MRI, patients will have a baseline serum creatinine test within 24 hours prior to Ablavar administration, will sign an Informed Consent (IC) form, and will undergo a brief medical history assessment on the day of and prior to Ablavar administration.

A standardized NSF questionnaire will be administered to the patient at 48 (+ or -12) hours, 1 month (+ or - 1 week), 3 months (+ or - 2 weeks), 6 (+ or - 1) months, and 18 (+ or - 1) months post-dose. At 12 (+ or - 1) months, and at 24 (+ or - 1) months, patients will return to the clinic for a limited examination for skin abnormalities and formal review of signs and symptoms suggestive of NSF.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Nephrogenic Systemic Fibrosis

Intervention

Ablavar

Location

Mennitt - Weill Cornell Medical College
New York
New York
United States
10065

Status

Not yet recruiting

Source

Lantheus Medical Imaging

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:15-0400

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