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LMI - Ablavar - 401 - Study of Incidence of Nephrogenic Systemic Fibrosis(NSF) in Kidney Disease Patients Undergoing MRI With Ablavar

Information source: Lantheus Medical Imaging
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nephrogenic Systemic Fibrosis

Intervention: Ablavar (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Lantheus Medical Imaging

Official(s) and/or principal investigator(s):
Kevin Mennitt, MD, Principal Investigator, Affiliation: Weil-Cornell Medical College

Overall contact:
Stephen Schmitz, MD, Phone: 978-671-7307, Email: stephen.schmitz@lantheus.com

Summary

Study Design:

In this phase 4 study, all patients will receive 1 dose of Ablavar as part of an MRI examination in their routine clinical management.

A standardized NSF questionnaire will be administered to the patient at various time points

post-dose. At 1 year and 2 years (+1 or - 1 month) patients will return to the clinic for a

limited examination for skin abnormalities and formal review of signs and symptoms suggestive of NSF.

Clinical Details

Official title: A Phase 4, Open-Label, Prospective Evaluation of the Incidence of NSF in Patients With Moderate to Severe Kidney Disease Undergoing MRI With Ablavar (in Routine Clinical Practice

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Incidence of Nephrogenic Systemic Fibrosis

Secondary outcome: Incidence of Severe Adverse Events (SAEs) & Adverse Events (AEs)

Detailed description: Study Design:

This 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, 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 acheiving 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

Locations and Contacts

Stephen Schmitz, MD, Phone: 978-671-7307, Email: stephen.schmitz@lantheus.com

Mennitt - Weill Cornell Medical College, New York, New York 10065, United States
Additional Information

Starting date: June 2010
Last updated: June 15, 2010

Page last updated: October 04, 2010

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