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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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8 October 2021 |
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Main ID: |
EUCTR2007-000229-23-FR |
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Date of registration:
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04/06/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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RENAL SAFETY EVALUATION AFTER DOTAREM-ENHANCED MRA COMPARED WITH NON-ENHANCED MRI IN PATIENTS AT HIGH RISK OF DEVELOPING CONTRAST MEDIUM INDUCED NEPHROPATHY.
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Scientific title:
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RENAL SAFETY EVALUATION AFTER DOTAREM-ENHANCED MRA COMPARED WITH NON-ENHANCED MRI IN PATIENTS AT HIGH RISK OF DEVELOPING CONTRAST MEDIUM INDUCED NEPHROPATHY. |
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Date of first enrolment:
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24/08/2007 |
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Target sample size:
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134 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-000229-23 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: comparative descriptive
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: Comparator will be an examination without contrast media injection(unenhanced-MRI)
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Belgium
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France
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Italy
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Spain
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Key inclusion & exclusion criteria
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Inclusion criteria:
·Male or female, aged = 55 years;
·Patient presenting with a known stable stage III to stage IV renal insufficiency according to the K/DOQI definition, i.e., 15 < estimated GFR < 60 ml/min/1.73m² according to MDRD formula for 2 consecutive values (within 10% of each other) obtained over at least one week apart with the most recent value having been obtained within 24 hours prior to the study procedure;
·Patient scheduled to undergo a contrast enhanced MR Angiography or unenhanced MRI examination to specify a diagnosis;
·Patient able to understand and provide written informed consent to participate in the trial;Patient for whom blood samples can be obtained in the 24 hours preceding the procedure and 72 hours after the examination.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
·Patient with a contraindication to MRI (e.g., pacemaker, aneurysm clip, severe claustrophobia, metallic joint replacement or others according to the imaging laboratory's standard practice);
·Patient who has a diagnosis of a hemodynamic instability (cardiogenic shock – persistent systolic pressure < 90 requiring inotropic support) or acute myocardial infraction within 15 days prior the inclusion;
·Patient who needs hemodialysis;
·Patient with known allergy to gadolinium chelates (only applicable for patient undergoing Dotarem-enhanced MRA);
·Patient receiving medications known to be nephrotoxic or to cause increases in serum creatinine level (i.e. selective inhibitors of cyclo-oxygenase 2, anti-Vascular Endothelium Growth Factors, Vancomycine, Aciclovir, aminoglycosides, amphotericin B, polymixin, platinium complexes and non-steroidal anti-inflammatory treatment except Acetyl Salicylic Acid) within 24 hours before first blood sample and during 72 hours after the procedure;
·Patients for whom the dosage of diuretic has been modified during the month prior the inclusion or should be modified during the 3 days after the imaging procedure
·Patients planned to either undergo surgery or receive chemotherapy within 72 hours post-procedure (i.e: before the blood test 72 hours post-procedure);
·Patient having an imaging procedure (with contrast media or not ) within 7 days of entering this protocol;
·Patient with a planned imaging procedure (with contrast media or not ) within 72 hours post-procedure;
·Patient with newly discovered unstable diabetes;
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Patients suffering from renal insufficiency and scheduled for contrast enhanced-MR angiography or unenhanced-MRI
MedDRA version: 10.0
Level: LLT
Classification code 10038474
Term:
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Intervention(s)
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Trade Name: DOTAREM 0.5 mmol/ml
Product Name: DOTAREM 0.5mmol/m, solution for injection
Product Code: Not applicable
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Gadoteric Acid (corresponding to DOTA+gadolinium oxide)
Other descriptive name: 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetic acid, Gadolinium complex
Concentration unit: mmol/ml millimole(s)/millilitre
Concentration type: equal
Concentration number: 0.5-
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Primary Outcome(s)
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Primary end point(s): The evaluation of the renal tolerance after both procedures (MRI and DOTAREM®-MRA) will be done by assessing the serum creatinine levels from blood sampling taken within 24 hours before the imaging procedure and at 72 ±12 hours after the procedure.
This study will calculate in the two groups the percentage of patients presenting with a significant creatinine level increase according to the approach described hereafter.
Significant creatinine level increase (Nephrotoxicity) will be defined as a rise in serum creatinine level at 72±12 hours of at least 25% or 0.5mg/dl (=44.2µmol/l) compared to baseline.
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Secondary Objective: -To confirm the clinical and biological safety of DOTAREM® by assessing vital signs, laboratory parameters and adverse events through a 72±12 hours post treatment (DOTAREM®) or post procedure follow-up period.
-To assess the serum creatinine level fluctuation in term of mean difference between baseline and 72 ±12 hours after examination.
-To evaluate the estimated Glomerular Filtration Rate fluctuation in term of percentage and mean difference between baseline and 72 ±12 hours after examination. Estimated GFR will be assessed using the MDRD study equation.
-If possible, to assess the potential influence of hydration protocol and/or prophylactic treatment on the renal function
In case of rise in Serum creatinine level at 72±12 hours of at least 25% or 0.5mg/dl (44.2µmol/l), to observe the percentage of patients returned at baseline level within 14 days after the last blood sample (at 72hours).
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Main Objective: To assess in at risk patients (patients with at least moderate renal insufficiency) the frequency of contrast-induced nephropathy after Dotarem-enhanced MRA, in comparison with the frequency of nephropathy after unenhanced MRI and to observe an equivalence between both procedures regarding these frequencies.
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Secondary ID(s)
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DGD 44-044
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not applicable
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 24/08/2007
Contact:
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