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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lantheus Medical Imaging
ClinicalTrials.gov Identifier:
NCT01135316
First received: June 1, 2010
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Nephrogenic Systemic Fibrosis
Drug: Ablavar

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Lantheus Medical Imaging:

Primary Outcome Measures:
  • Incidence of Nephrogenic Systemic Fibrosis [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of Severe Adverse Events (SAEs) & Adverse Events (AEs) [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

whole blood, tissue


Enrollment: 2
Study Start Date: October 2009
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Ablavar
    One dose of Ablavar will be administered for use during a contrast MRI examination
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with moderate to severe kidney disease

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 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01135316

Locations
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10022
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Lantheus Medical Imaging
Investigators
Study Director: Simon P Robinson, PhD Lantheus Medical Imaging
  More Information

No publications provided

Responsible Party: Lantheus Medical Imaging
ClinicalTrials.gov Identifier: NCT01135316     History of Changes
Other Study ID Numbers: LMI-Ablavar-401
Study First Received: June 1, 2010
Last Updated: May 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Lantheus Medical Imaging:
NSF, Ablavar, Kidney Disease, Magnetic Resonance Imaging (MRI),

Additional relevant MeSH terms:
Fibrosis
Kidney Diseases
Nephrogenic Fibrosing Dermopathy
Pathologic Processes
Urologic Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 29, 2014