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

Completed

• Conditions: Nephrogenic Systemic Fibrosis

• Registration Number: NCT01135316
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-06-01
• Study First Submitted QC: 2010-06-01
• Study First Posted: 2010-06-02
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-05
• Last Update Posted: 2014-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Nephrogenic Systemic Fibrosis	24 months

Secondary Outcome Measures

Name	Time	Method
Incidence of Severe Adverse Events (SAEs) & Adverse Events (AEs)	48 hours

Trial Locations

Locations (2)

Weill Cornell Medical College; 🇺🇸 New York, New York, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States