Renal Safety Evaluation After Dotarem®-Enhanced MRI (RESCUE)

Guerbet

Status and phase

Completed

Phase 4

Conditions

Renal Insufficiency

Treatments

Drug: Dotarem®-enhanced MRI

Other: non-enhanced MRI

Study type

Interventional

Funder types

Industry

Identifiers

NCT00650845

DGD-44-044

Details and patient eligibility

About

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.

Full 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.

Enrollment

135 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.