Clinical trial NCT00650845: Renal Safety Evaluation After Dotarem®-Enhanced MRI
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Insufficiency
Keywords: contrast-induced nephropathy, creatinemia
Lead sponsor: Guerbet
Sponsor class: INDUSTRY
First posted: 2008-04-02
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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 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.

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 groups of patients were defined on the basis of the planned imaging procedure selected to obtain a diagnosis: those undergoing a Dotarem®-enhanced MRI and those undergoing an unenhanced MRI.

A clinically significant increase in serum creatinine levels after the contrast-enhanced MRI exam was used as an indication of contrast induced nephrotoxicity. A blood test was performed 24h before the MRI in order to evaluate baseline creatinine values. 72h after the exam, a second blood test was performed. An increase in creatinemia above 25% from baseline levels was defined as a contrast-induced nephrotoxic reaction. The primary endpoint of the study assessed the percentage of patients presenting a contrast-induced nephrotoxic reaction in order to show a non inferiority of enhanced as compared to non-enhanced MRI exams.

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.

Primary outcomes:
measure: 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.
timeFrame: baseline pre MRI and 3 days post MRI
measure: 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.
timeFrame: Baseline pre MRI and 3 days post MRI
Secondary outcomes:
measure: Percent Change of Serum Creatinine Level From Baseline to 72±24 Hours After Examination, in the Full Analysis Set Population.
timeFrame: Baseline pre MRI and 3 days post MRI
measure: Percent Change of Serum Creatinine Level Variation From Baseline to 72±24 Hours After Examination, in the Per Protocol Population
timeFrame: Baseline pre MRI and 3 days post MRI
measure: Percent Change of Estimated Glomerular Filtration Rate (eGFR) Values From Baseline to 72±24 Hours After Examination, in the Full Analysis Set Population
timeFrame: Baseline pre MRI and 3 days post MRI
measure: eGFR Values Variation Between Baseline and 72±24 Hours After Examination, in the Per Protocol Population
timeFrame: Baseline pre MRI and 3 days post MRI
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Onze Lievevrouwziekenhuis
city: Gent
country: Belgium
facility: University Hospital Ghent
city: Roeselare
country: Belgium
facility: Alg. Inwendige Ziekten -Nierziekten
city: Bordeaux
country: France
facility: Groupe Hospitalier Pellegrin
city: Lille
country: France
facility: Hôpital A. Calmette
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Paris
country: France
facility: Hopital Pitie Salpetriere
city: Paris
country: France
facility: Hopital Bichat
city: Paris
country: France
facility: Hôpital Tenon
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Tours
country: France
facility: Hôpital Trousseau
city: Ferrara
country: Italy
facility: Azienda Ospedaliera Universitaria di Ferrara
city: Genova
country: Italy
facility: Ente Ospedaliero Ospedali Galliera,
city: Madrid
country: Spain
facility: Hospital San Carlos
city: Valencia
country: Spain
facility: Hospital Dr PESET
Study officials:
affiliation: Groupe Hospitalier Pitie-Salpetriere
name: Gilbert Deray, Pr, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: