Renal Safety Evaluation After Dotarem-enhanced MRI (RESCUE)
This study has been completed.
Sponsor:
Guerbet
Information provided by (Responsible Party):
Guerbet
ClinicalTrials.gov Identifier:
NCT00650845
First received: March 4, 2008
Last updated: August 24, 2011
Last verified: August 2011
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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
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 |
ClinicalTrials.gov processed this record on May 23, 2013