NCT01449266

Safety and Dialysability of Dotarem® in Dialysed Patients

Safety and Dialysability of Dotarem® in Dialysed Patients - Phase 1 Clinical Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Guerbet · Industry
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• End-stage Renal Failure

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-03-01
• Completion: 2012-06-01
• First posted: 2011-10-10
• Last updated: 2015-07-08
• Results posted: 2015-06-08

Locations

1 site across 1 country: Belgium