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Completed

NCT Number: NCT01376739

Magnevist Post-marketing Surveillance in Japan

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.

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Key information

Conditions

Diagnostic Imaging

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Drug

Patients who will need to undergo contrast enhanced MR angiography with Magnevist (a dosage of more than 0.2 mg/kg)

Primary outcomes

  1. Incidence of adverse drug reactions and serious adverse events in subjects who received Magnevist

    Time frame: After Magnevist administration, up to 3 years

  2. 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

Secondary outcomes

  1. 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

  2. Incidence of adverse drug reactions in subpopulation with baseline data

    Time frame: At baseline and after Magnevist administration, up to 3 years

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Drug Use Investigation of Magnevist

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jun 20, 2011
Registry last updated
Jun 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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