Phase 4
N=132
Renal Safety Evaluation After Dotarem®-Enhanced MRI
Renal Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT00650845 ↗Enrolled (actual)
132
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: 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. — 1; 0 Number of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dotarem®-enhanced MRI (Drug); non-enhanced MRI (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Guerbet
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
1; 0 | — |
| PRIMARY 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. |
1; 0 | — |
| SECONDARY Percent Change of Serum Creatinine Level From Baseline to 72±24 Hours After Examination, in the Full Analysis Set Population. |
-1.40; -3.48 | 0.291 |
| SECONDARY Percent Change of Serum Creatinine Level Variation From Baseline to 72±24 Hours After Examination, in the Per Protocol Population |
0.05; -5.17 | 0.040 sig |
| SECONDARY Percent Change of Estimated Glomerular Filtration Rate (eGFR) Values From Baseline to 72±24 Hours After Examination, in the Full Analysis Set Population |
3.02; 5.55 | 0.301 |
| SECONDARY eGFR Values Variation Between Baseline and 72±24 Hours After Examination, in the Per Protocol Population |
1.37; 7.58 | 0.051 |
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 controversial. The aim of this study was to evaluate the safety profile of gadoterate meglumine (Dotarem®) in patients with chronic renal insufficiency by evaluating the rate of patients experiencing contrast-induced nephrotoxicity following the injection of gadoterate meglumine.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00650845). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.