Magnevist Post-marketing Surveillance in Japan

Drug Use Investigation of Magnevist

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.

Study Overview

• Status: Completed
• Conditions: Diagnostic Imaging
• Intervention / Treatment: Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)

• Study Type: Observational
• Enrollment (Actual): 2051

Contacts and Locations

Study Locations

• Japan
  • Many Locations, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The target population of this study is patients who received Magnevist for MR angiography. The study is expected to collect data of 2,000 patients in approximately 150 hospitals in Japan.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
Incidence of adverse drug reactions in subpopulation with baseline data	At baseline and after Magnevist administration, up to 3 years

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: June 8, 2011
• First Submitted That Met QC Criteria: June 16, 2011
• First Posted (Estimate): June 20, 2011

Study Record Updates

• Last Update Posted (Estimate): June 20, 2011
• Last Update Submitted That Met QC Criteria: June 16, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Magnevist; MR angiography
• Other Study ID Numbers: 15035; MAGNEVIST

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No