Magnevist Post-marketing Surveillance in Japan
Drug Use Investigation of Magnevist
2 other identifiers
observational
2,051
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2007
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 8, 2011
CompletedFirst Posted
Study publicly available on registry
June 20, 2011
CompletedJune 20, 2011
June 1, 2011
2.8 years
June 8, 2011
June 16, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
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
Study Arms (1)
Group 1
Interventions
Patients who will need to undergo contrast enhanced MR angiography with Magnevist (a dosage of more than 0.2 mg/kg)
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Patients who are contraindicated based on the product label
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (1)
Unknown Facility
Many Locations, Japan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 8, 2011
First Posted
June 20, 2011
Study Start
August 1, 2007
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
June 20, 2011
Record last verified: 2011-06