Comparison of 4.0 mg/kg Sugammadex at 1-2 Post Tetanic Counts (PTC) in Renal or Control Patients (19.4.328)(P05769)

A Multi-center, Parallel-group, Comparative Trial Evaluating the Efficacy, Pharmacokinetics and Safety of 4.0 mg/kg Sugammadex Administered at 1-2 PTC in Subjects With Normal or Severely Impaired Renal Function

The current trial was designed to investigate the effects of 4.0 mg.kg-1 of sugammadex on efficacy, safety and pharmacokinetics in subjects with severe renal impairment in comparison to subjects with normal renal function.

The results of previous trials showed that the safety profile of sugammadex

observed in subjects with impaired renal function are not appreciably different from subjects with normal renal function. Reoccurrence of neuromuscular blockade was not observed, and sugammadex was safe and generally well tolerated in subjects with severe renal impairment. In a previous trial, subjects (n=15) with severe renal impairment received a dose of 2.0 mg.kg-1 of sugammadex. The effects of the other proposed recommended dose for routine reversal, 4.0 mg.kg-1, on efficacy, safety and pharmacokinetics had not been studied thus far in subjects with severe renal impairment. The objectives of this trial were to assess equivalence with respect to the efficacy of sugammadex in subjects with normal renal function or severe renal impairment, to evaluate the safety of sugammadex in these subject groups and to compare the pharmacokinetic profiles.

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 control group)

-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

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 the sponsor, within 30 days of entering into 19.4.328 (P05769)

• Female subjects who are pregnant
• Female subjects who are breast-feeding