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Renal Safety Evaluation After Dotarem-Enhanced MRA (RESCUE)
This study is currently recruiting participants.
Verified by Guerbet, November 2008
Sponsored by: Guerbet
Information provided by: Guerbet
ClinicalTrials.gov Identifier: NCT00650845
  Purpose

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

Drug Information available for: Creatinine
U.S. FDA Resources
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

Further study details as provided by Guerbet:

Primary Outcome Measures:
  • frequency of contrast-induced nephropathy [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]

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)
Intervention Details:
    Biological: Biological exam
    The only intervention is biological examination including creatinine assay.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Study Population

Male or female, > or equal 18 years

Criteria

Inclusion Criteria:

  • Male or female, > or equal 18 years ;
  • Patient with a known stable renal insufficiency ;
  • Patient scheduled to undergo an MRI examination to specify a diagnosis ;
  • Patient able to understand and provide written informed consent to participate in the trial ;

Exclusion Criteria:

  • Patient with a contra-indication to MRI ;
  • Patient who has a diagnosis of an hemodynamic instability or acute myocardial infarction within 15 days prior the inclusion ;
  • Patient who needs hemodialysis ;
  • Patient with known allergy to gadolinium chelates ;
  • Patient receiving medications known to be nephrotoxic or to cause increases in serum creatinine level within 2 weeks before the inclusion ;
  • Patients planned to either undergo surgery or receive chemotherapy ;
  • Any condition which, based on the investigator's clinical judgement, would prevent the patient from completing all trial assessments and visits ;
  • Patient under guardianship and/or inability or unwillingness to cooperate with the requirements of this trial ;
  • Patient with newly discovered unstable diabetes.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00650845

Contacts
Contact: Corinne Dubourdieu, PhD +33145915000 ext 51 84 corinne.dubourdieu@guerbet-group.com

Locations
France
Guerbet Recruiting
Roissy CdG Cedex, France, 95943
Principal Investigator: Guerbet            
Sponsors and Collaborators
Guerbet
  More Information

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

Keywords provided by Guerbet:
Patients at high risks of developing contrast medium induced nephropathy

Study placed in the following topic categories:
Urologic Diseases
Kidney Diseases

ClinicalTrials.gov processed this record on January 16, 2009