Prospective Evaluation of the Incidence of NSF in Patients With Kidney Disease Undergoing MR
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
1 other identifier
observational
2
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2009
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 1, 2010
CompletedFirst Posted
Study publicly available on registry
June 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedMay 7, 2014
May 1, 2014
3.9 years
June 1, 2010
May 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Nephrogenic Systemic Fibrosis
24 months
Secondary Outcomes (1)
Incidence of Severe Adverse Events (SAEs) & Adverse Events (AEs)
48 hours
Interventions
One dose of Ablavar will be administered for use during a contrast MRI examination
Eligibility Criteria
Patients with moderate to severe kidney disease
You may qualify if:
- Kidney Disease with GFR \< 60 mL/min./1.73 m\^2. Clinical Need to Receive an MRI with Contrast. Understand \& Sign Informed Consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Weill Cornell Medical College
New York, New York, 10022, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Biospecimen
whole blood, tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Simon P Robinson, PhD
Lantheus Medical Imaging
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2010
First Posted
June 2, 2010
Study Start
October 1, 2009
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
May 7, 2014
Record last verified: 2014-05