Safety and Dialysability of Dotarem® in Dialysed Patients
To evaluate the dialysability of Dotarem®, after an IV injection of 0.1 mmol/kg in patients with chronic renal failure who require hemodialysis treatment.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Safety and Dialysability of Dotarem® in Dialysed Patients - Phase 1 Clinical Study|
- Dialysability of Dotarem® in dialysed patients [ Time Frame: Dotarem® dialysability assessed up to 4 days after the Dotarem® administration ] [ Designated as safety issue: Yes ]To evaluate the seric concentration of Gadolinium, after an IV injection of 0.1 mmol/kg in patients with chronic renal failure who require hemodialysis treatment.
- Safety of Dotarem® in dialysed patients [ Time Frame: Safety assessed from the patient's inclusion until the last follow-up visit 3 months after the Dotarem® administration ] [ Designated as safety issue: Yes ]To evaluate the biological and clinical safety of Dotarem by assessing vital signs, biological parameters, injection-site tolerance, through a 4-day post injection follow-up, adverse events through a 3-week post injection period and serious adverse events through a 3-month post injection period.
|Study Start Date:||November 2011|
|Study Completion Date:||June 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Experimental: Single arm
Male or female, aged ≥18 years
• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)
Dotarem® will be administered at a dose of 0.1 mmoL/kg (0.2 mL/kg).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01449266
|Clinical Pharmacology Unit Antwerp|
|Principal Investigator:||Sofie Mesens, MD||Clinical Pharmacology Unit Antwerp, Belgium|