Comparison of 4.0 mg/kg Sugammadex at 1-2 PTC in Renal or Control Patients (19.4.328) - Full Text View

Sponsored by:	Organon
Information provided by:	Organon
ClinicalTrials.gov Identifier:	NCT00702715

Purpose

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

Condition	Intervention	Phase
Anesthesia	Drug: sugammadex	Phase III

Genetics Home Reference related topics: ataxia-telangiectasia

MedlinePlus related topics: Anesthesia Ataxia Telangiectasia

Drug Information available for: Rocuronium ORG 9426 Sugammadex

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	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 Function

Further study details as provided by Organon:

Primary Outcome Measures:

Time from start of administration of sugammadex to recovery of the T4/T1 ratio to 0.9. (not safety, during neuromuscular monitoring) [ Time Frame: after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time from start of administration of sugammadex to recovery of the T4/T1 ratio to 0.7 and 0.8 [ Time Frame: after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	September 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 4.0 mg.kg-1 sugammadex in subjects with severe renal impairment	Drug: 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 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.
2: Experimental 4.0 mg.kg-1 sugammadex in subjects with normal renal function	Drug: 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 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.

Arms

Assigned Interventions

1: Experimental

4.0 mg.kg-1 sugammadex in subjects with severe renal impairment

Drug: 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 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.

2: Experimental

4.0 mg.kg-1 sugammadex in subjects with normal renal function

Drug: 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 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.

Detailed Description:

The results of previous trials showed that the safety profiles 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 well tolerated in subjects with severe renal impairment. In a previous trial, subjects with impaired renal function 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 have not been studied thus far in subjects with severe renal impairment. Furthermore, only 15 subjects with severe renal impairment were studied in the previous trial, and thus the amount of data collected in this patient population is limited. The objectives of this trial are to show equivalence with respect to the efficacy of sugammadex in subjects with normal or severely impaired renal function, to evaluate the safety of sugammadex in these subject groups and to compare the pharmacokinetic profiles.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 medication in a dose and/or at a time point known to interfere with NMBAs, such as antibiotics, anticonvulsants and Mg2+
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702715

Contacts

Contact: SP Clinical Trial Registry Call Center

1-888-772-8734

Locations

Netherlands
Investigational Site 101	Recruiting
Nijmegen, Netherlands
United Kingdom
Investigational Site 106	Recruiting
Manchester, United Kingdom

Sponsors and Collaborators

Organon

More Information

Responsible Party:	NV Organon ( Study Director )
Study ID Numbers:	19.4.328, P05769
Study First Received:	June 19, 2008
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00702715
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Ataxia-Telangiectasia
Rocuronium
Ataxia Telangiectasia

ClinicalTrials.gov processed this record on January 15, 2009