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Safety of Gadovist in Renally Impaired Patients

NCT00828737 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 927

Last updated 2016-02-18

No results posted yet for this study

Summary

Patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging (MRI) scan and injection with a contrast agent, Gadovist, will be asked to participate.

The administration of contrast agents that contain gadolinium such as Gadovist might increase a potential risk to develop a rare condition called nephrogenic systemic fibrosis (NSF) in patients with renal impairment. This study is to assess the potential risk to develop NSF in patients with renal impairment after the administration of Gadovist. Patients who are enrolled in this study will receive a Gadovist enhanced MRI scan which was prescribed by the referring doctor. After the MRI scan the patient will be included in a two year follow-up period to assess if signs or symptoms suggestive of NSF have appeared.

Conditions

Interventions

DRUG

Gadobutrol (Gadovist, BAY86-4875)

Gadovist in approved indications at approved dosages

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • Australia
  • Austria
  • Canada
  • France
  • Germany
  • Italy
  • South Korea
  • Spain
  • Switzerland
  • Thailand

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00828737 on ClinicalTrials.gov