Renal Safety Evaluation After Dotarem-enhanced MRI (RESCUE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guerbet
ClinicalTrials.gov Identifier:
NCT00650845
First received: March 4, 2008
Last updated: August 24, 2011
Last verified: August 2011
  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
Drug: Dotarem
Procedure: non-enhanced MRI
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Renal Safety Evaluation After Dotarem-enhanced MRI Compared With Non-enhanced MRI in Patients at High Risk of Developing Contrast Medium Induced Nephropathy

Resource links provided by NLM:


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
Study Completion Date: August 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dotarem Drug: Dotarem
Single IV administration
Non-enhanced MRI Procedure: non-enhanced MRI
non injected MRI

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00650845

Locations
France
Guerbet
Roissy CdG Cedex, France, 95943
Sponsors and Collaborators
Guerbet
  More Information

No publications provided

Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT00650845     History of Changes
Other Study ID Numbers: DGD-44-044
Study First Received: March 4, 2008
Last Updated: August 24, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Spanish Agency of Medicines
Belgium: Ministry of Social Affairs, Public Health and the Environment
Italy: Ministry of Health

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

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Contrast Media
Gadoterate meglumine
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014