Renal Safety Evaluation After Dotarem®-Enhanced MRI

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00650845
• Date of registration: 04/03/2008
• Prospective Registration: No
• Primary sponsor: Guerbet
• Public title: Renal Safety Evaluation After Dotarem®-Enhanced MRI RESCUE
• Scientific title: Renal Safety Evaluation After Dotarem®-Enhanced MRI Compared With Non-enhanced MRI in Patients at High Risk of Developing Contrast Medium Induced Nephropathy
• Date of first enrolment: January 2008
• Target sample size: 135
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00650845
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

Belgium, France, Italy, Spain

Contacts

• Name: Gilbert Deray, Pr, MD, PhD
• Affiliation: Groupe Hospitalier Pitie-Salpetriere

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Renal Insufficiency

Intervention(s)

Other: non-enhanced MRI

Drug: Dotarem®-enhanced MRI

Primary Outcome(s)

Number of Patients Presenting Contrast-induced Nephropathy as Defined by an Increase in Serum Creatinine Levels of at Least 25% Over Baseline Levels, in the Per Protocol Population. [Time Frame: Baseline pre MRI and 3 days post MRI]

Number of Patients Presenting Contrast-induced Nephropathy as Defined by an Increase in Serum Creatinine Levels of a Least 25% Over Baseline Levels, in the Full Analysis Set Population. [Time Frame: baseline pre MRI and 3 days post MRI]

Secondary Outcome(s)

Percent Change of Serum Creatinine Level From Baseline to 72±24 Hours After Examination, in the Full Analysis Set Population. [Time Frame: Baseline pre MRI and 3 days post MRI]

Percent Change of Serum Creatinine Level Variation From Baseline to 72±24 Hours After Examination, in the Per Protocol Population [Time Frame: Baseline pre MRI and 3 days post MRI]

eGFR Values Variation Between Baseline and 72±24 Hours After Examination, in the Per Protocol Population [Time Frame: Baseline pre MRI and 3 days post MRI]

Percent Change of Estimated Glomerular Filtration Rate (eGFR) Values From Baseline to 72±24 Hours After Examination, in the Full Analysis Set Population [Time Frame: Baseline pre MRI and 3 days post MRI]

Secondary ID(s)

DGD-44-044

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 09/06/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00650845