A multi-center, parallel-group, comparative trial evaluating the efficacy, pharmacokinetics and safety of 4.0 mg.kg-1 sugammadex administered at 1-2 PTC in subjects with normal or severely impaired renal functio

Phase 3

Completed

• Conditions: renal impairment; 10038430

• Registration Number: NL-OMON33656
• Lead Sponsor: Schering-Plough

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

Creatinine clearance (CLCR) < 30 mL/min for severe renal impairment group, CLCR >= 80 mL/min for control group

Exclusion Criteria

Known or suspected allergy to narcotics, muscle relaxants or other medication used during general anesthesia

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To show equivalence with respect to the efficacy of sugammadex in subjects with<br /><br>normal or severely impaired renal function</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To compare the pharmacokinetics of sugammadex in subjects with normal or<br /><br>severely impaired renal function<br /><br>To evaluate the safety of sugammadex in subjects with normal or severely<br /><br>impaired renal function</p><br>