Risk of Nephrogenic Systemic Fibrosis (NSF) in Patients With Moderate to Severe Renal Insufficiency After the Administration of Magnevist - Full Text View

Purpose

Assess potential risk for NSF in subjects with renal impairment (moderate/severe) post magnevist injection. Subjects will be screened with in 48 hours of previously scheduled MRI, those meeting the enrollment criteria will be enrolled prior to MRI and followed for 2 years post MRI with visits occuring at 1yr and 2 yr timepoints, in addition follow-up phone calls conducted at 1, 3, 6 and 18 months to assess for skin changes suggestive of NSF.

Condition	Intervention	Phase
Fibrosis Kidney Failure Renal Insufficiency	Procedure: Lab sample drawn for serum chemistry at baseline visit	Phase IV

MedlinePlus related topics:

Kidney Failure

Drug Information available for:

Gadolinium dtpa BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Other, Non-Randomized, Open Label, Single Group Assignment, Safety Study

Official Title:	Prospective Non-Randomized Observational (Pharmacoepidemiologic) Cohort Study (Open-Label, Multicenter) to Assess the Magnitude of Potential Risk With the Administration of Magnevist Injection in Patients With Moderate to Severe Renal Impairment for the Development of Nephrogenic Systemic Fibrosis (NSF) Based on Biopsy Confirmation, or of Cutaneous Changes Consistent With NSF.

Further study details as provided by Bayer:

Primary Outcome Measures:

Number of subjects with onset of biopsy confirmed NSF or cutaneous skin changes consistent with NSF following the administration of Magnevist within the 2 year follow-up period [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Describe potential co-factors or risk modulators for the development of biopsy confirmed NSF or cutaneous skin changes consistent with NSF, including degree of disease, time of onset, clinical course, inflammatory events, vascular injuries, etc. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1000
Study Start Date:	October 2008
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1	Procedure: Lab sample drawn for serum chemistry at baseline visit Patients will be followed for 2 years after the administration of Magnevist at the approved dose to see if symptoms consistent with NSF develop

Eligibility

Ages Eligible for Study:	2 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must have moderate (eGFR 30-59 ml/min/1.73 m2) to severe (eGFR <30 ml/min/1.73 m2) renal impairment and be scheduled for a contrast enhanced MRI with Magnevist Injection at the recommended dose of 0.1 mmol/kg.

Exclusion Criteria:

Gadolinium Based Contrast Agent enhanced MRI within 12 months prior to administration of Magnevist; History of NSF; Clinically unstable or age <2 yrs.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744939

Contacts


Contact: Bayer Clinical Trials Contact		clinical-trials-contact@bayerhealthcare.com

Contact: For trial location information (Phone Menu Options "3" or "4")	(+)1-888-84 22937

Locations


United States, Arizona

	Phoenix, Arizona, United States, 85008-4956

United States, California

	Santa Rosa, California, United States, 95403

	Los Angeles, California, United States, 90033-1029

United States, Colorado

	Pueblo, Colorado, United States, 81008

United States, Connecticut

	New Haven, Connecticut, United States, 06520-8064

United States, Florida

	Jacksonville, Florida, United States, 32209

United States, Hawaii

	Honolulu, Hawaii, United States, 96859-5000

United States, Maryland

	Baltimore, Maryland, United States, 21287

United States, Massachusetts

	Boston, Massachusetts, United States, 02118

	Boston, Massachusetts, United States, 02114-2696

United States, New York

	Stony Brook, New York, United States, 11794

United States, North Carolina

	Greenville, North Carolina, United States, 27834

United States, Ohio

	Cleveland, Ohio, United States, 44195

United States, Pennsylvania

	Philadelphia, Pennsylvania, United States, 19104

	Danville, Pennsylvania, United States, 17822-2001

United States, Virginia

	Charlottesville, Virginia, United States, 22908

United States, Washington

	Seattle, Washington, United States, 98101

Sponsors and Collaborators

Bayer

Investigators


Study Director:	Bayer Study Director	Bayer

More Information

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Responsible Party:	Bayer Healthcare Pharmaceuticals Inc. ( Medical Affairs Therapeutic Area Head )
Study ID Numbers:	13256, 312141
First Received:	August 20, 2008
Last Updated:	September 30, 2008
ClinicalTrials.gov Identifier:	NCT00744939
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Gadolinium

NSF

Renal Impairment

chemically induced

adverse effects

Contrast Media

complications

Study placed in the following topic categories:

Renal Insufficiency

Urologic Diseases

Fibrosis

Nephrogenic Fibrosing Dermopathy

Kidney Diseases

Kidney Failure

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on October 24, 2008

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00744939