RENAL SAFETY EVALUATION AFTER DOTAREM-ENHANCED MRA COMPARED WITH NON-ENHANCED MRI IN PATIENTS AT HIGH RISK OF DEVELOPING CONTRAST MEDIUM INDUCED NEPHROPATHY.

Phase 1

• Conditions: Patients suffering from renal insufficiency and scheduled for contrast enhanced-MR angiography or unenhanced-MRI; MedDRA version: 10.0Level: LLTClassification code 10038474Term: <Manually entered code. Term in E.1.1>

• Registration Number: EUCTR2007-000229-23-FR
• Lead Sponsor: GUERBET

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-04
• Study Completion: 2011-05-09
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 134

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;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified