An observational study in Nephrogenic Systemic Fibrosis, sponsored by Lantheus Medical Imaging. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-07.
Sponsored by Lantheus Medical Imaging · Observational
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.
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 2 is below the median of 192 across 1,033 observational studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Lantheus Medical Imaging is the lead sponsor of 30 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with moderate to severe kidney disease
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.
One dose of Ablavar will be administered for use during a contrast MRI examination
Incidence of Nephrogenic Systemic Fibrosis
Time frame: 24 months
Incidence of Severe Adverse Events (SAEs) & Adverse Events (AEs)
Time frame: 48 hours
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Lantheus Medical Imaging