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

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 70

Inclusion Criteria

• At least 18 years of age
• ASA class 1-3
• Creatinine clearance (CLcr) < 30 mL/min and no anticipated clinical indication for high flux hemodialysis during first 24 hours after sugammadex administration (for renally impaired group) or CLcr = 80 mL/min (for controlgroup)
• Scheduled for a surgical procedure under general anesthesia with propofol requiring neuromuscular relaxation with the use of rocuronium
• Scheduled for a surgical procedure in supine position
• Written informed consent
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 scheduled for renal transplant surgery
• 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 receiving fusidic acid, toremifene and/or flucloxacillin
• 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 19.4.328
• 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 show equivalence with respect to the efficacy of sugammadex in subjects with normal or severely impaired renal function;<br> Secondary Objective: • To evaluate the safety of sugammadex in subjects with normal or severely impaired renal function<br> • To compare the pharmacokinetics of sugammadex in subjects with normal or severely impaired renal function<br> ;Primary end point(s): The time from start of administration of sugammadex to recovery of the T4/T1 ratio to 0.9.

Secondary Outcome Measures

Name	Time	Method

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