Safety of Contrast enhanced MRI diagnoses in patients suffering from some chronic kidney disease stage 3 (cohort 1) or stage 4 to 5 (cohort 2) MedDRA version: 9.1 Level: LLT Classification code 10029820 MedDRA version: 9.1 Level: SOC Classification code 10038359
Conditions
Interventions
Trade Name: PROHANCE
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Gadoteridol
Concentration unit: mmol/kg millimole(s)/kilogram
Concentration type: equal
Concentration number: .1-
Sponsors
BRACCO IMAGING
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Provides written informed consent and is willing to comply with protocol requirements Is going to receive or has received PROHANCE injection during an MRI examination; Has CKD with eGFR stably comprised between 30 and 59 mL/min/1.73m2, (cohort 1) or below 30 mL/min/1.73m2 (cohort 2)as calculated from a SCr value obtained from the local laboratory within 24 hours prior to the PROHANCE injection (Cohort 1). Are the trial subjects under 18? yes 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
Exclusion criteria: Has received a GBCA within the past 12 months prior to inclusion in this study; Has unstable kidney function (only for cohort 1); Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data and achieving study objectives; Has ever been suspected of, or diagnosed with, NSF prior to the study-specific MRI; Is unable or unwilling to return for necessary office visits, to be examined by dermatologists or to undergo further evaluations should development of NSF be suspected.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this long-term, study is to prospectively compare the incidence of NSF in two cohorts: Coohort 1: patients with moderate Chronic Kidney Disease (CKD stage 3) Coohort 2: patients with severe Chronic Kidney Disease (CKD stages 4 and 5);Secondary Objective: to compare,if possible, patients with CKD stage 4 with CKD at stage 5;Primary end point(s): the conclusion of the follow-up period of two years | — |
Countries
France, Italy
Outcome results
None listed