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

May 21, 2015 updated by: Guerbet

Renal Safety Evaluation After Dotarem®-Enhanced MRI Compared With Non-enhanced MRI in Patients at High Risk of Developing Contrast Medium Induced Nephropathy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

135

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
        • Onze Lievevrouwziekenhuis
      • Gent, Belgium, 9000
        • University Hospital Ghent
      • Roeselare, Belgium, 8800
        • Alg. Inwendige Ziekten -Nierziekten
  • France
      • Bordeaux, France, 33076
        • Groupe Hospitalier Pellegrin
      • Lille, France, 59037
        • Hôpital A. Calmette
      • Lyon, France, 69437
        • Hôpital Edouard Herriot
      • Paris, France, 75020
        • Hôpital Tenon
      • Paris, France, 75013
        • Hopital Pitie Salpetriere
      • Paris, France, 75018
        • Hôpital Bichat
      • Strasbourg, France, 67000
        • CHU Strasbourg
      • Tours, France, 37044
        • Hôpital Trousseau
  • Italy
      • Ferrara, Italy, 44100
        • Azienda Ospedaliera Universitaria di Ferrara
      • Genova, Italy, 16128
        • Ente Ospedaliero Ospedali Galliera,
  • Spain
      • Madrid, Spain, 28040
        • Hospital San Carlos
      • Valencia, Spain, 46017
        • Hospital Dr Peset

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dotarem®-enhanced MRI
Patients undergoing Dotarem®-enhanced MRI for diagnostic purposes
Drug: Dotarem®-enhanced MRI
Single IV administration before MRI exam
Other Names:
  • Gadoterate meglumine
  • Gadoteric acid
Other: Non-enhanced MRI
Patients undergoing non-enhanced MRI for diagnostic purposes
Other: non-enhanced MRI
non injected MRI
Other Names:
  • unenhanced MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Comparing the number of patients experiencing an increase of creatinine of at least 25% over baseline levels after Dotarem®-enhanced MRI and after non-enhanced MRI in patients with at least a moderate renal insufficiency.
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 at Least 25% Over Baseline Levels, in the Per Protocol Population.
Time Frame: Baseline pre MRI and 3 days post MRI
Comparing the number of patients experiencing an increase of creatinine of at least 25% over baseline levels after Dotarem®-enhanced MRI and after non-enhanced MRI in patients with at least a moderate renal insufficiency.
Baseline pre MRI and 3 days post MRI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Serum creatinine levels were measured at baseline and at 72±24 hours after examination. The percentage of change in creatinemia from baseline was calculated for both the Dotarem® and the non-enhanced groups.
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
Serum creatinine levels were measured at baseline and at 72±24 hours after examination. The percentage of change in creatinemia from baseline was calculated for both the Dotarem® and the non-enhanced groups.
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
eGFR was assessed using creatinemia and the Modification of Diet in Renal Disease (MDRD) study equation. eGFR were evaluated in terms of mean difference between the pre- and post-MRI procedure. The eGFR variation was expressed as a percentage of change from baseline values.
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
eGFR (estimated Glomerular Filtration Rate) was assessed using creatinemia and the Modification of Diet in Renal Disease (MDRD) study equation. eGFR were evaluated in terms of mean difference between the pre- and post-MRI procedure. The eGFR variation was expressed as a percentage of change from baseline values.
Baseline pre MRI and 3 days post MRI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guerbet

Investigators

  • Principal Investigator: Gilbert Deray, Pr, MD, PhD, Groupe Hospitalier Pitie-Salpetriere

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

March 4, 2008

First Submitted That Met QC Criteria

April 1, 2008

First Posted (Estimate)

April 2, 2008

Study Record Updates

Last Update Posted (Estimate)

June 9, 2015

Last Update Submitted That Met QC Criteria

May 21, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DGD-44-044

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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