Risk of Nephrogenic Systemic Fibrosis (NSF) in Patients With Moderate Renal Insufficiency After the Administration of Magnevist

NCT ID: NCT00744939

Last Updated: 2014-09-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

168 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2013-11-30

Brief Summary

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Assess potential risk for NSF in subjects with renal impairment (moderate) post magnevist injection. Subjects will be screened within 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.

Detailed Description

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Conditions

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Fibrosis Kidney Failure Renal Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Participants received Magnevist in accordance with its labeling

Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Intervention Type DRUG

Patients will be followed for 2 years after the administration of Magnevist at the approved dose to see if symptoms consistent with NSF develop

Interventions

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Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Patients will be followed for 2 years after the administration of Magnevist at the approved dose to see if symptoms consistent with NSF develop

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients must have moderate (eGFR 30-59 ml/min/1.73 m\^2) 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 (other then Magnevist) enhanced MRI within 12 months prior to administration of Magnevist
* History of NSF
* Clinically unstable or age \<2 yrs
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Phoenix, Arizona, United States

Site Status

Chula Vista, California, United States

Site Status

Los Angeles, California, United States

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Santa Rosa, California, United States

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Pueblo, Colorado, United States

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New Haven, Connecticut, United States

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Jacksonville, Florida, United States

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Honolulu, Hawaii, United States

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Honolulu, Hawaii, United States

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Topeka, Kansas, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

Site Status

Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Brooklyn, New York, United States

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New York, New York, United States

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Stony Brook, New York, United States

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Cleveland, Ohio, United States

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Danville, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Memphis, Tennessee, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Charlottesville, Virginia, United States

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Tacoma, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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X312141

Identifier Type: OTHER

Identifier Source: secondary_id

13256

Identifier Type: -

Identifier Source: org_study_id

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