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

Nephrogenic Systemic Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01135316
• Other study ID #: LMI-Ablavar-401
• Status: Completed
• Phase: N/A
• First received: June 1, 2010
• Last updated: May 5, 2014
• Start date: October 2009
• Est. completion date: September 2013

Study information

• Verified date: May 2014
• Source: Lantheus Medical Imaging
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fibrosis
• Kidney Diseases
• Nephrogenic Fibrosing Dermopathy
• Nephrogenic Systemic Fibrosis

Intervention

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

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	Weill Cornell Medical College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Lantheus Medical Imaging

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Nephrogenic Systemic Fibrosis		24 months	Yes
Secondary	Incidence of Severe Adverse Events (SAEs) & Adverse Events (AEs)		48 hours	Yes