Renal InsufficiencyPhase 4RESCUENCT00650845
Renal Safety Evaluation After Dotarem®-Enhanced MRI
A Phase 4 study testing Dotarem®-enhanced MRI and non-enhanced MRI in people with Renal Insufficiency, run by Guerbet at 15 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency
- What is being tested?
- Dotarem®-enhanced MRI and non-enhanced MRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 15 sitesin 4 countries
- Study dates
- Jan 2008to Aug 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 ;
Who cannot join
- 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 ;
Show all 9Show fewer
- 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.
Trial locations and contacts
15 sites in 4 countries.
15 sites in 4 countries
France8 sites
Groupe Hospitalier Pellegrin
Bordeaux, 33076
Hôpital A. Calmette
Lille, 59037
Hôpital Edouard Herriot
Lyon, 69437
Hopital Pitie Salpetriere
Paris, 75013
Hopital Bichat
Paris, 75018
Hôpital Tenon
Paris, 75020
CHU Strasbourg
Strasbourg, 67000
Hôpital Trousseau
Tours, 37044
Belgium3 sites
Onze Lievevrouwziekenhuis
Aalst, 9300
University Hospital Ghent
Ghent, 9000
Alg. Inwendige Ziekten -Nierziekten
Roeselare, 8800
Italy2 sites
Azienda Ospedaliera Universitaria di Ferrara
Ferrara, 44100
Ente Ospedaliero Ospedali Galliera,
Genova, 16128
About this study
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
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.
Read the 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.
- Conditions
- Renal Insufficiency
- Being tested
- Dotarem®-enhanced MRI, non-enhanced MRI
- Keywords
- contrast-induced nephropathy, creatinemia
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dotarem®-enhanced MRIDrug
Also called Gadoterate meglumine, Gadoteric acid
Single IV administration before MRI exam
non-enhanced MRIOther
Also called unenhanced MRI
non injected MRI
| Study group | Role | What they receive |
|---|---|---|
| Dotarem®-enhanced MRI | Experimental | Patients undergoing Dotarem®-enhanced MRI for diagnostic purposes Receives: Drug: Dotarem®-enhanced MRI |
| Non-enhanced MRI | Other | Patients undergoing non-enhanced MRI for diagnostic purposes Receives: Other: non-enhanced MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: Baseline pre MRI and 3 days post MRI
Secondary outcomes (4)
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline pre MRI and 3 days post MRI
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.
Measured: Baseline pre MRI and 3 days post MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2008 (estimated)
- Study startJan 2008
- Primary completionMay 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guerbet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilbert Deray, Pr, MD, PhD, Principal investigator, Groupe Hospitalier Pitie-Salpetriere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00650845
- Sponsor's protocol ID
- DGD-44-044
- Acronym
- RESCUE
- Status last verified
- Mar 2015
- First submitted
- 4 Mar 2008
- Last updated
- 9 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00650845
- Acronym / sponsor ID
- RESCUE / DGD-44-044
- Conditions
- Renal Insufficiency
- Keywords
- contrast-induced nephropathy, creatinemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- GuerbetIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- May 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 2 Apr 2008 (estimated)
- Results
- Posted 9 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dotarem®-enhanced MRI | Experimental | Drug: Dotarem®-enhanced MRIPatients undergoing Dotarem®-enhanced MRI for diagnostic purposes |
| Non-enhanced MRI | Other | Other: non-enhanced MRIPatients undergoing non-enhanced MRI for diagnostic purposes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 ;
Key exclusion criteria (9 listed)
- 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 ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dotarem®-enhanced MRIAlso: Gadoterate meglumine, Gadoteric acidSingle IV administration before MRI exam | Drug | Dotarem®-enhanced MRI |
| non-enhanced MRIAlso: unenhanced MRInon injected MRI | Other | Non-enhanced MRI |
Primary outcome
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.
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.
4 secondary outcomes
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
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
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 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilbert Deray, Pr, MD, PhD principal investigator
Groupe Hospitalier Pitie-Salpetriere
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dotarem®-enhanced MRI and non-enhanced MRI in people with Renal Insufficiency, run by Guerbet at 15 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France, Belgium, Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: baseline pre MRI and 3 days post MRI). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2015; AzTrials last refreshed its copy on 1 Nov 2026.