LMI-Ablavar-401 - Prospective Evaluation of the Incidence of Nephrogenic Systemic Fibrosis (NSF) in Patients With Kidney Disease Undergoing Ablavar (MRI) in Routine Clinical Practice

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, will undergo
a limited exam for skin abnormalities, 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.