Status:
COMPLETED
Renal Safety Evaluation After Dotarem®-Enhanced MRI
Lead Sponsor:
Guerbet
Conditions:
Renal Insufficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 controvers...
Detailed Description
Patients with renal insufficiency not requiring hemodialysis and scheduled to undergo a contrast enhanced MRI or unenhanced MRI examination to specify a diagnosis, were selected for inclusion. Two gro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT00650845
Start Date
January 1 2008
End Date
August 1 2011
Last Update
June 9 2015
Active Locations (15)
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1
Onze Lievevrouwziekenhuis
Aalst, Belgium, 9300
2
University Hospital Ghent
Ghent, Belgium, 9000
3
Alg. Inwendige Ziekten -Nierziekten
Roeselare, Belgium, 8800
4
Groupe Hospitalier Pellegrin
Bordeaux, France, 33076