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Sponsored by: |
Guerbet |
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Information provided by: | Guerbet |
ClinicalTrials.gov Identifier: | NCT00650845 |
Although there is a well documented risk of acute renal failure with the iodinated contrast agents, intravenous gadolinium-based contrast agents are considered non-nephrotoxic and have been widely used for Magnetic Resonance Imaging. The aim of this study is to confirm the good safety profile of DOTAREM in patients with chronic renal failure and other risk factors for nephrotoxicity.
Condition | Intervention | Phase |
---|---|---|
Nephropathy |
Biological: Biological exam |
Phase IV |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Renal Safety Evaluation After Dotarem-Enhanced MRA Compared With Non-Enhanced MRI in Patients at High Risk of Developing Contrast Medium Induced Nephropathy |
Estimated Enrollment: | 134 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Male or female, > or equal 18 years
Inclusion Criteria:
Exclusion Criteria:
Contact: Corinne Dubourdieu, PhD | +33145915000 ext 51 84 | corinne.dubourdieu@guerbet-group.com |
France | |
Guerbet | Recruiting |
Roissy CdG Cedex, France, 95943 | |
Principal Investigator: Guerbet |
Responsible Party: | GUERBET ( CORINNE DUBOURDIEU,PhD STUDY CHAIR ) |
Study ID Numbers: | DGD-44-044 |
Study First Received: | March 4, 2008 |
Last Updated: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00650845 |
Health Authority: | France: Afssaps - French Health Products Safety Agency; Spain: Spanish Agency of Medicines; Belgium: Ministry of Social Affairs, Public Health and the Environment |
Patients at high risks of developing contrast medium induced nephropathy |
Urologic Diseases Kidney Diseases |