A single center, open-label trial in subjects with severe renal impairment evaluating the dialysability of the sugammadex-rocuronium complex

Phase 1

• Conditions: ot applicable

• Registration Number: EUCTR2007-006934-33-BE
• Lead Sponsor: V Organon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-01-03
• Study Completion: 2009-07-08
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• At least 18 years of age
• ASA Class = 4
• Creatinine clearance (CLCR) < 30 mL/min and clinical indication for dialysis
• Hospitalization at ICU and scheduled for a (surgical) procedure under general anesthesia requiring neuromuscular relaxation with the use of rocuronium
• Scheduled for a (surgical) procedure in supine position
• Written informed consent (of the legal representative)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Subjects known or suspected to have neuromuscular disorders impairing neuromuscular blockade and/or significant hepatic dysfunction
• Subjects known or suspected to have a (family) history of malignant hyperthermia
• Subjects known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia
• Subjects who have already participated in a sugammadex trial
• Subjects who have participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into 19.4.333
• Female subjects who are pregnant*
• Female subjects who are breast-feeding

* In female subjects pregnancy will be excluded both from medical history and by an hCG test within 24 hours before surgery except in females who are not of childbearing potential, i.e. at least 2 years menopausal or have undergone tubal ligation or an hysterectomy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: • To evaluate the dialysability of the sugammadex-rocuronium complex in subjects with severe renal impairment<br>• To evaluate the safety of sugammadex in subjects with severe renal impairment<br>• To evaluate the efficacy of sugammadex in subjects with severe renal impairment<br>;Secondary Objective: ;Primary end point(s): • Dialysability of the sugammadex-rocuronium complex<br>• Time from start of administration of sugammadex to recovery of the T4/T1 ratio to 0.9<br>• Time from start of administration of sugammadex to recovery of the T4/T1 ratio to 0.8<br>• Time from start of administration of sugammadex to recovery of the T4/T1 ratio to 0.7<br>