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

NCT00702715 | Completed Phase 3 Results

• 2 other identifiers: P0576919.4.328
• Study Type: interventional
• Target: 69
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• Time to Recovery of the T4/T1 Ratio to 0.9.

  Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.

  start of administration of sugammadex to recovery from neuromuscular blockade

Secondary Outcomes (2)

• Time to Recovery of the T4/T1 Ratio to 0.8

  start of administration of sugammadex to recovery from neuromuscular blockade

• Time to Recovery of T4/T1 Ratio to 0.7

  start of administration of sugammadex to recovery from neuromuscular blockade

Study Arms (2)

Participants with severe renal impairment

EXPERIMENTAL

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.

Drug: sugammadex

Participants with normal renal function

ACTIVE COMPARATOR

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.

Drug: sugammadex

Interventions

sugammadex 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.

Also known as: Org 25959

Participants with normal renal function; Participants with severe renal impairment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 25829395 RESULT

MeSH Terms

Interventions

Sugammadex

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2008
• First Posted: June 20, 2008
• Study Start: September 24, 2008
• Primary Completion: March 15, 2010
• Study Completion: March 15, 2010
• Last Updated: May 16, 2017
• Results First Posted: April 11, 2011

Record last verified: 2017-04