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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guerbet
ClinicalTrials.gov Identifier:
NCT00650845
First received: March 4, 2008
Last updated: May 21, 2015
Last verified: March 2015
  Purpose

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.


Condition Intervention Phase
Renal Insufficiency
Drug: Dotarem®-enhanced MRI
Other: non-enhanced MRI
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Guerbet:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 135
Study Start Date: January 2008
Study Completion Date: August 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Non-enhanced MRI
Patients undergoing non-enhanced MRI for diagnostic purposes
Other: non-enhanced MRI
non injected MRI
Other Name: unenhanced MRI

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00650845

Locations
Belgium
Onze Lievevrouwziekenhuis
Aalst, Belgium, 9300
University Hospital Ghent
Gent, Belgium, 9000
Alg. Inwendige Ziekten -Nierziekten
Roeselare, Belgium, 8800
France
Groupe Hospitalier Pellegrin
Bordeaux, France, 33076
Hôpital A. Calmette
Lille, France, 59037
Hôpital Edouard Herriot
Lyon, France, 69437
Hôpital Tenon
Paris, France, 75020
Hopital Pitie Salpetriere
Paris, France, 75013
Hopital Bichat
Paris, France, 75018
CHU Strasbourg
Strasbourg, France, 67000
Hôpital Trousseau
Tours, France, 37044
Italy
Azienda Ospedaliera Universitaria di Ferrara
Ferrara, Italy, 44100
Ente Ospedaliero Ospedali Galliera,
Genova, Italy, 16128
Spain
Hospital San Carlos
Madrid, Spain, 28040
Hospital Dr PESET
Valencia, Spain, 46017
Sponsors and Collaborators
Guerbet
Investigators
Principal Investigator: Gilbert Deray, Pr, MD, PhD HOPITAL PITIE-SALPETRIERE
  More Information

No publications provided

Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT00650845     History of Changes
Other Study ID Numbers: DGD-44-044
Study First Received: March 4, 2008
Results First Received: March 11, 2015
Last Updated: May 21, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Spanish Agency of Medicines
Belgium: Ministry of Social Affairs, Public Health and the Environment
Italy: Ministry of Health

Keywords provided by Guerbet:
contrast-induced nephropathy, creatinemia

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Gadoterate meglumine
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 30, 2015