Magnevist Post-marketing Surveillance in Japan

Diagnostic Imaging Clinical Trial

Official title:

Drug Use Investigation of Magnevist

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01376739
• Other study ID #: 15035
• Secondary ID: MAGNEVIST
• Status: Completed
• Phase: N/A
• First received: June 8, 2011
• Last updated: June 16, 2011
• Start date: August 2007
• Est. completion date: June 2010

Study information

• Verified date: June 2011
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2051
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Exclusion Criteria:

• Patients who are contraindicated based on the product label

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diagnostic Imaging

Intervention

Drug:
• Gadopentetate dimeglumine (Magnevist, BAY86-4882)
Patients who will need to undergo contrast enhanced MR angiography with Magnevist (a dosage of more than 0.2 mg/kg)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse drug reactions and serious adverse events in subjects who received Magnevist		After Magnevist administration, up to 3 years	Yes
Primary	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	Yes
Secondary	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	No
Secondary	Incidence of adverse drug reactions in subpopulation with baseline data		At baseline and after Magnevist administration, up to 3 years	Yes

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