Magnevist Post-marketing Surveillance in Japan

Completed

• Conditions: Diagnostic Imaging
• Interventions: Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)

• Registration Number: NCT01376739
• Lead Sponsor: Bayer

Brief Summary

This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Magnevist at a dose of more than 0.2 ml/kg for MR angiography of peripheral vasculature with continuous imaging from the abdomen to the lower extremities. The objective of this study is to assess safety, especially in relation to renal dysfunction, and efficacy of using Magnevist in clinical practice. A total 2,000 patients will be recruited.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2011-06
• Study First Submitted: 2011-06-08
• Study First Submitted QC: 2011-06-16
• Last Update Submitted: 2011-06-16
• Study First Posted: 2011-06-20
• Last Update Posted: 2011-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2051

Inclusion Criteria

• Patients who received a dose of more than 0.2 mg/kg of Magnevist for MR angiography of peripheral vasculature with continuous imaging from the abdomen to the lower extremities

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Exclusion Criteria

• Patients who are contraindicated based on the product label

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Gadopentetate dimeglumine (Magnevist, BAY86-4882)	-

Primary Outcome Measures

Name	Time	Method
Incidence of adverse drug reactions and serious adverse events in subjects who received Magnevist	After Magnevist administration, up to 3 years
Incidence of adverse drug reactions, especially Nephrogenic Systemic Fibrosis and Nephrogenic Fibrosing Dermopathy (NSF/NFD) in patients with reduced renal functions	After Magnevist administration, up to 3 years

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse drug reactions in subpopulation with baseline data	At baseline and after Magnevist administration, up to 3 years
MRI image evaluation assessment by the four rank scales of 1 to 4: 1) sufficient extraction; 2) almost sufficient extraction; 3) not sufficient extraction; and 4) insufficient extraction	After Magnevist injection, up to 3 years