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

NCT ID: NCT00702715

Last Updated: 2017-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-24
• Study Completion Date: 2010-03-15

Brief Summary

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.

Detailed Description

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.

Conditions

Anesthesia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Participants with severe renal impairment

Participants with severe renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Severe renal impairment was defined as creatinine clearance \<30mL/min.

Group Type: EXPERIMENTAL

sugammadex

Intervention Type: DRUG

Each subject will receive an

intravenous (i.v.) single bolus dose of 0.6 mg.kg-1 rocuronium. After

this dose, maintenance doses of 0.1 - 0.2 mg.kg-1

rocuronium may be given. In case of maintenance dosing, the target depth of

neuromuscular blockade has to be maintained at 1-2 post-tetanic counts (PTC). After the last dose of rocuronium has been administered, the subject will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC.

Participants with normal renal function

Participants with normal renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Normal renal function was defined as creatinine clearance \>=80mL/min.

Group Type: ACTIVE_COMPARATOR

sugammadex

Intervention Type: DRUG

Each subject will receive an

intravenous (i.v.) single bolus dose of 0.6 mg.kg-1 rocuronium. After

this dose, maintenance doses of 0.1 - 0.2 mg.kg-1

rocuronium may be given. In case of maintenance dosing, the target depth of

neuromuscular blockade has to be maintained at 1-2 post-tetanic counts (PTC). After the last dose of rocuronium has been administered, the subject will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC.

Interventions

sugammadex

Each subject will receive an

intravenous (i.v.) single bolus dose of 0.6 mg.kg-1 rocuronium. After

this dose, maintenance doses of 0.1 - 0.2 mg.kg-1

rocuronium may be given. In case of maintenance dosing, the target depth of

neuromuscular blockade has to be maintained at 1-2 post-tetanic counts (PTC). After the last dose of rocuronium has been administered, the subject will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC.

Intervention Type: DRUG

Other Intervention Names

Org 25959

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Panhuizen IF, Gold SJ, Buerkle C, Snoeck MM, Harper NJ, Kaspers MJ, van den Heuvel MW, Hollmann MW. Efficacy, safety and pharmacokinetics of sugammadex 4 mg kg-1 for reversal of deep neuromuscular blockade in patients with severe renal impairment. Br J Anaesth. 2015 May;114(5):777-84. doi: 10.1093/bja/aet586. Epub 2015 Mar 31.

Reference Type: RESULT

PMID: 25829395 (View on PubMed)

Other Identifiers

19.4.328

Identifier Type: -

Identifier Source: secondary_id

P05769

Identifier Type: -

Identifier Source: org_study_id