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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: A Phase 4, Open-Label, Prospective Evaluation of the Incidence of Nephrogenic Systemic Fibrosis (NSF) in Patients With Moderate to Severe Kidney Disease Undergoing Magneti

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Lantheus Medical Imaging

Current Primary Outcome: Incidence of Nephrogenic Systemic Fibrosis [ Time Frame: 24 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Incidence of Severe Adverse Events (SAEs) & Adverse Events (AEs) [ Time Frame: 48 hours ]

Original Secondary Outcome: Same as current

Information By: Lantheus Medical Imaging

Dates:
Date Received: June 1, 2010
Date Started: October 2009
Date Completion:
Last Updated: May 5, 2014
Last Verified: May 2014