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:
Conditions
Interventions
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 (co
Sponsors
GUERBET
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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). ;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. | — |
Countries
Belgium, France, Italy, Spain
Outcome results
None listed