Safety and Dialysability of Dotarem® in Dialysed Patients
|End-stage Renal Failure||Drug: Dotarem® IV injection at 0.1 mmol/kg||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (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 Dotarem® administration ]To evaluate the decrease in seric concentration of gadolinium, after each hemodialysis session of patients injected with 0.1 mmol/kg of Dotarem® . The percent change of gadolinium concentration is calculated by estimating the amount of serum gadolinium before and after each hemodialysis session. Calculations are performed only for subjects with concentration above the lower limit of quantification (LLQ)
- Safety of Dotarem® in Dialysed Patients Evaluated by the Number of Patients Experiencing Adverse Events. [ Time Frame: Safety assessed from patients inclusion until the last follow-up visit 3 months after Dotarem® administration ]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)|
Male or female subjects, aged ≥18 years,suffering from end-stage renal failure and requiring hemodialysis treatment 3 times per week, were submitted to a single Dotarem® IV injection at 0.1 mmol/kg before being submitted to 3 hemodialysis sessions to assess the decrease of Dotarem® concentration in the blood.
Drug: Dotarem® IV injection at 0.1 mmol/kg
Dotarem® was IV administered at a dose of 0.1 mmoL/kg (0.2 mL/kg).
Ten adult patients suffering from end stage renal failure and requiring hemodialysis treatment for 3 times were enrolled. Patients received a single dose of Dotarem® at 0.1 mmol/kg before being submitted to hemodialysis to assess the dialysability of Dotarem® . After injection of Dotarem®, 3 sessions of hemodialysis were performed as follows:
The first hemodialysis session started between 1 to 2 h after the injection; The second hemodialysis session occurred 2 days (i.e., 48 ± 2 h) after the Dotarem® injection; The third hemodialysis session occurred 4 days (i.e., 96 ± 4 h) after the Dotarem® injection.
The decrease in serum Dotarem® concentration was assessed after each hemodialysis session. Safety assessments included adverse events (AEs), vital signs, injection-site tolerance, and laboratory assessments.Two safety follow-up visits were performed: one 3 weeks (± 2 days) and one 3 months (± 4 days) after the Dotarem® injection.
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|