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Renal Safety Evaluation After Dotarem®-Enhanced MRI

NCT00650845 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2015-06-09

Study results available
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Summary

Although there is a well documented risk of acute renal failure with the iodinated contrast agents, the implication of intravenous gadolinium-based contrast agents in nephrotoxicity remains controversial. The aim of this study was to evaluate the safety profile of gadoterate meglumine (Dotarem®) in patients with chronic renal insufficiency by evaluating the rate of patients experiencing contrast-induced nephrotoxicity following the injection of gadoterate meglumine.

Conditions

  • Renal Insufficiency

Interventions

DRUG

Dotarem®-enhanced MRI

Single IV administration before MRI exam

OTHER

non-enhanced MRI

non injected MRI

Sponsors & Collaborators

  • Guerbet

    lead INDUSTRY

Principal Investigators

  • Gilbert Deray, Pr, MD, PhD · Groupe Hospitalier Pitie-Salpetriere

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2011-05-31
Completion
2011-08-31

Countries

  • Belgium
  • France
  • Italy
  • Spain

Study Locations

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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 NCT00650845 on ClinicalTrials.gov