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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)

Phase: N/A

Status: Completed

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.

Clinical Details

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)

Detailed description: 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria: Kidney Disease with GFR < 60 mL/min./1. 73 m^2. Clinical Need to Receive an MRI with Contrast. Understand & Sign Informed Consent. Exclusion Criteria: 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 NSF manifestations. 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 suspected.

Locations and Contacts

Weill Cornell Medical College, New York, New York 10022, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

Additional Information

Starting date: October 2009
Last updated: May 5, 2014

Page last updated: August 23, 2015

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