Prospective Evaluation of the Incidence of NSF in Patients With Kidney Disease Undergoing MR
Information source: Lantheus Medical Imaging
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nephrogenic Systemic Fibrosis
Intervention: Ablavar (Drug)
Sponsored by: Lantheus Medical Imaging
Official(s) and/or principal investigator(s):
Simon P Robinson, PhD, Study Director, Affiliation: Lantheus Medical Imaging
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.
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 Magnetic Resonance Imaging (MRI) With Ablavar (Gadofosveset Trisodium) in Routine Clinical Practice
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Incidence of Nephrogenic Systemic Fibrosis
Secondary outcome: Incidence of Severe Adverse Events (SAEs) & Adverse Events (AEs)
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
Minimum age: 18 Years.
Maximum age: N/A.
Kidney Disease with GFR < 60 mL/min./1. 73 m^2. Clinical Need to Receive an MRI with
Contrast. Understand & Sign Informed Consent.
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
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
Locations and Contacts
Weill Cornell Medical College, New York, New York 10022, United States
Duke University Medical Center, Durham, North Carolina 27710, United States
Starting date: October 2009
Last updated: May 5, 2014