Safety and Dialysability of Dotarem® in Dialysed Patients

End-stage Renal Failure Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• End-stage Renal Failure
• Kidney Failure, Chronic

• NCT number: NCT01449266
• Study type: Interventional
• Source: Guerbet
• Status: Completed
• Phase: Phase 1
• Start date: November 2011
• Completion date: June 2012