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

Phase 1

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

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-12-14
• Study Completion: 2011-05-09
• Last Update Posted: 4 January 2022

Recruitment & Eligibility

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

Inclusion Criteria

·Male or female, aged = 18 years;
Female of childbearing potential must have effective contraception (contraceptive pill or Intra-Uterine Device), or be surgically sterilized, or post-menopausal (minimum 12 months of amenorrhea) or must have a documented negative urine or blood pregnancy test at screening;
·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; stability will be demonstrated with 2 consecutive values (within 15% of each other): a previous value obtained at least one week in advance (not more than 6 months in advance) and the most recent one obtained prior to the study procedure, on the same day or on the day before;
·Patient scheduled to undergo a contrast enhanced MRI or unenhanced MRI examination to specify a diagnosis;
.Patient receiving angiotensin-converting enzyme inhibitors, angiotensine II receptor blockers (sartans), diuretics and fibrates, must be receiving these drug(s) at stable dosage(s) for at least 2 weeks; in addition the dosage(s) should not be modified for the whole study duration (i.e., until 72 hours +/-24 hrs or 14 days after the imaging procedure);
·Patient able to understand and having provided written informed consent to participate in the trial;
.Patient for whom blood samples can be obtained on the day of the imaging procedure or on the day before and 72 hours (+ or - 24h) 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 MRI);
Patients receiving anticalcineurine drugs, such as ciclosporine, unless the patient has been having a stable (variation =15%) creatinine level for at least 6 months, as demonstrated with available creatinine values, and has been receiving the drug at stable dosage for at least 6 months; this dosage should not be modified for the whole study duration (i.e., until 72 hours +/-24 hrs or 14 days after the imaging procedure);
·Patient receiving any other medications known to be nephrotoxic or to cause increases in serum creatinine level (e.g., selective inhibitors of cyclo-oxygenase 2, anti-vascular Endothelium Growth Factors, vancomycine, aciclovir, aminoglycosides, amphotericin B, polymixin, platinium complexes, non-steroidal anti-inflammatory treatment except acetyl salicylic acid, etc.) within 2 weeks before first blood sample and for the whole study duration (i.e., until 72 hours +/-24 hrs or 14 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 had an imaging procedure (MRI or CT imaging, with contrast medium or not ) within 7 days of entering this protocol;
·Patient with a planned imaging procedure (MRI or CT imaging, with contrast medium or not ) within 72 hours post-procedure;
·Patient with newly discovered unstable diabetes (i.e. <1month, glycaemia >= 2.5g);

Study & Design

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