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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Nephrogenic Systemic Fibrosis

Intervention / Treatment
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* Drug: Ablavar


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ablavar|One dose of Ablavar will be administered for use during a contrast MRI examination|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Nephrogenic Systemic Fibrosis |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Severe Adverse Events (SAEs) & Adverse Events (AEs) |  | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSF, Ablavar, Kidney Disease, Magnetic Resonance Imaging (MRI),