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

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ClinicalTrials.gov Identifier: NCT01135316
Recruitment Status : Completed
First Posted : June 2, 2010
Last Update Posted : May 7, 2014
Information provided by (Responsible Party):
Lantheus Medical Imaging

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.

Condition or disease Intervention/treatment
Nephrogenic Systemic Fibrosis Drug: Ablavar

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.

Study Type : Observational
Actual Enrollment : 2 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : October 2009
Primary Completion Date : September 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Intervention Details:
    Drug: Ablavar
    One dose of Ablavar will be administered for use during a contrast MRI examination

Primary Outcome Measures :
  1. Incidence of Nephrogenic Systemic Fibrosis [ Time Frame: 24 months ]

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

Biospecimen Retention:   Samples With DNA
whole blood, tissue

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with moderate to severe kidney disease

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01135316

United States, New York
Weill Cornell Medical College
New York, New York, United States, 10022
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Lantheus Medical Imaging
Study Director: Simon P Robinson, PhD Lantheus Medical Imaging

Responsible Party: Lantheus Medical Imaging
ClinicalTrials.gov Identifier: NCT01135316     History of Changes
Other Study ID Numbers: LMI-Ablavar-401
First Posted: June 2, 2010    Key Record Dates
Last Update Posted: May 7, 2014
Last Verified: May 2014

Keywords provided by Lantheus Medical Imaging:
NSF, Ablavar, Kidney Disease, Magnetic Resonance Imaging (MRI),

Additional relevant MeSH terms:
Kidney Diseases
Nephrogenic Fibrosing Dermopathy
Pathologic Processes
Urologic Diseases
Skin Diseases