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

Primary Purpose

Renal Insufficiency

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Dotarem®-enhanced MRI
non-enhanced MRI
Sponsored by
Guerbet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Renal Insufficiency focused on measuring contrast-induced nephropathy, creatinemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Onze Lievevrouwziekenhuis
  • University Hospital Ghent
  • Alg. Inwendige Ziekten -Nierziekten
  • Groupe Hospitalier Pellegrin
  • Hôpital A. Calmette
  • Hôpital Edouard Herriot
  • Hopital Pitie Salpetriere
  • Hopital Bichat
  • Hôpital Tenon
  • CHU Strasbourg
  • Hôpital Trousseau
  • Azienda Ospedaliera Universitaria di Ferrara
  • Ente Ospedaliero Ospedali Galliera,
  • Hospital San Carlos
  • Hospital Dr PESET

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Dotarem®-enhanced MRI

Non-enhanced MRI

Arm Description

Patients undergoing Dotarem®-enhanced MRI for diagnostic purposes

Patients undergoing non-enhanced MRI for diagnostic purposes

Outcomes

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.
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.
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.
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
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
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
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.

Full Information

First Posted
March 4, 2008
Last Updated
May 21, 2015
Sponsor
Guerbet
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1. Study Identification

Unique Protocol Identification Number
NCT00650845
Brief Title
Renal Safety Evaluation After Dotarem®-Enhanced MRI
Acronym
RESCUE
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

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guerbet

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency
Keywords
contrast-induced nephropathy, creatinemia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dotarem®-enhanced MRI
Arm Type
Experimental
Arm Description
Patients undergoing Dotarem®-enhanced MRI for diagnostic purposes
Arm Title
Non-enhanced MRI
Arm Type
Other
Arm Description
Patients undergoing non-enhanced MRI for diagnostic purposes
Intervention Type
Drug
Intervention Name(s)
Dotarem®-enhanced MRI
Other Intervention Name(s)
Gadoterate meglumine, Gadoteric acid
Intervention Description
Single IV administration before MRI exam
Intervention Type
Other
Intervention Name(s)
non-enhanced MRI
Other Intervention Name(s)
unenhanced MRI
Intervention Description
non injected MRI
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
baseline pre MRI and 3 days post MRI
Title
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.
Description
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.
Time Frame
Baseline pre MRI and 3 days post MRI
Secondary Outcome Measure Information:
Title
Percent Change of Serum Creatinine Level From Baseline to 72±24 Hours After Examination, in the Full Analysis Set Population.
Description
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.
Time Frame
Baseline pre MRI and 3 days post MRI
Title
Percent Change of Serum Creatinine Level Variation From Baseline to 72±24 Hours After Examination, in the Per Protocol Population
Description
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.
Time Frame
Baseline pre MRI and 3 days post MRI
Title
Percent Change of Estimated Glomerular Filtration Rate (eGFR) Values From Baseline to 72±24 Hours After Examination, in the Full Analysis Set Population
Description
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.
Time Frame
Baseline pre MRI and 3 days post MRI
Title
eGFR Values Variation Between Baseline and 72±24 Hours After Examination, in the Per Protocol Population
Description
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.
Time Frame
Baseline pre MRI and 3 days post MRI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilbert Deray, Pr, MD, PhD
Organizational Affiliation
Groupe Hospitalier Pitie-Salpetriere
Official's Role
Principal Investigator
Facility Information:
Facility Name
Onze Lievevrouwziekenhuis
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
University Hospital Ghent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Alg. Inwendige Ziekten -Nierziekten
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Groupe Hospitalier Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hôpital A. Calmette
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Hopital Pitie Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hopital Bichat
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Hôpital Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
CHU Strasbourg
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Hôpital Trousseau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Azienda Ospedaliera Universitaria di Ferrara
City
Ferrara
ZIP/Postal Code
44100
Country
Italy
Facility Name
Ente Ospedaliero Ospedali Galliera,
City
Genova
ZIP/Postal Code
16128
Country
Italy
Facility Name
Hospital San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Dr PESET
City
Valencia
ZIP/Postal Code
46017
Country
Spain

12. IPD Sharing Statement

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Renal Safety Evaluation After Dotarem®-Enhanced MRI

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