Magnevist Post-marketing Surveillance in Japan

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01376739
First received: June 8, 2011
Last updated: June 16, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Diagnostic Imaging
Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Drug Use Investigation of Magnevist

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Incidence of adverse drug reactions and serious adverse events in subjects who received Magnevist [ Time Frame: After Magnevist administration, up to 3 years ] [ Designated as safety issue: Yes ]
  • Incidence of adverse drug reactions, especially Nephrogenic Systemic Fibrosis and Nephrogenic Fibrosing Dermopathy (NSF/NFD) in patients with reduced renal functions [ Time Frame: After Magnevist administration, up to 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: After Magnevist injection, up to 3 years ] [ Designated as safety issue: No ]
  • Incidence of adverse drug reactions in subpopulation with baseline data [ Time Frame: At baseline and after Magnevist administration, up to 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 2051
Study Start Date: August 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01376739

Locations
Japan
Many Locations, Japan
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Head Medical Development Japan, Bayer Yakuhin Co. LTD.
ClinicalTrials.gov Identifier: NCT01376739     History of Changes
Other Study ID Numbers: 15035, MAGNEVIST
Study First Received: June 8, 2011
Last Updated: June 16, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Bayer:
Magnevist
MR angiography

ClinicalTrials.gov processed this record on April 16, 2014