Renal safety evaluation after dotarem-enhanced MRI compared with non-enhanced MRI in patients at high risk of developing contrast medium induced nephropathy - RESCUE

Conditions: Patient with at least moderate renal insuffiency and scheduled to undergo a contrast enhanced MRI or unenhanced MRI.
MedDRA version: 12.1Level: LLTClassification code 10038474Term: Renal insufficiency

Registration Number: EUCTR2007-000229-23-IT

Lead Sponsor: GUERBET

Brief Summary: Not available

Detailed Description: Not available

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/1.73m? 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 ? 24hrs 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 (? 24 hrs) after the examination; Patient with National health insurance.
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 haemodialysis; Patient with known allergy to gadolinium chelates (only applicable for patient undergoing Dotarem-enhanced MRI); Patient 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 ? 24hrs or 14 days after the imaging procedure); Patient receiving any other medication 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 ? 24hrs 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 72 hours post-procedure blood test); 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 having participated in any investigational drug study within 30 days prior the study enrolment or planned to participate within 72 hours post-procedure; 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 (i.e. < 1 month, glycaemia ≥ 2.5g/l).