NCT00656799

Dialysis of Sugammadex in Participants With Severe Renal Impairment (Study 19.4.333) (P05773)

A Single Center, Open-Label Trial in Subjects With Severe Renal Impairment Evaluating the Dialysability of the Sugammadex-Rocuronium Complex

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The clinical trial objectives were to evaluate the dialysability of the sugammadex-rocuronium complex; it's safety and efficacy in participants with severe renal impairment.

Detailed description

The current trial was designed to evaluate the dialysability of the sugammadex-rocuronium complex in participants with severe renal impairment. A dose of 4.0 mg/kg sugammadex was administered 15 minutes after administration of 0.6 mg/kg rocuronium. Blood and dialysate samples were collected before, during and after hemodialysis/filtration, for calculation of clearance of sugammadex-rocuronium complex and assessment of rebound.

Conditions

• Neuromuscular Blockade

Interventions

Type	Name	Description
DRUG	sugammadex	At 15 minutes after administration of rocuronium, an IV single bolus dose of 4.0 mg/kg sugammadex was administered.
DRUG	Rocuronium	After achieving stable anesthesia an IV single bolus dose of 0.6 mg/kg rocuronium was administered

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2008-04-11
• Last updated: 2015-03-10
• Results posted: 2013-07-31