Comparison of 4.0 mg/kg Sugammadex at 1-2 Post Tetanic Counts (PTC) in Renal or Control Patients (19.4.328)(P05769AM1)

This study has been completed.

Sponsor:

Information provided by:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00702715

First received: June 19, 2008

Last updated: March 15, 2011

Last verified: March 2011

History of Changes

Results First Received: March 15, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Anesthesia
Intervention:	Drug: sugammadex

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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 post-tetanic counts (PTC). Severe renal impairment was defined as creatinine clearance <30mL/min.
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.

Participant Flow: Overall Study

	Participants With Severe Renal Impairment	Participants With Normal Renal Function
STARTED	35	33 ^[1]
COMPLETED	34	33
NOT COMPLETED	1	0
Lost to Follow-up	1	0

[1]	One subject was enrolled but did not start study

Baseline Characteristics

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Reporting Groups

	Description
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.
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.
Total	Total of all reporting groups

Baseline Measures

	Participants With Severe Renal Impairment	Participants With Normal Renal Function	Total
Number of Participants [units: participants]	35	33	68
Age [units: years] Mean ± Standard Deviation	57 ± 16	45 ± 15	51 ± 16
Gender [units: participants]
Female	17	13	30
Male	18	20	38

Outcome Measures

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1. Primary:

Time to Recovery of the T4/T1 Ratio to 0.9. [ Time Frame: start of administration of sugammadex to recovery from neuromuscular blockade ]

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Measure Type	Primary
Measure Title	Time to Recovery of the T4/T1 Ratio to 0.9.
Measure Description	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.
Time Frame	start of administration of sugammadex to recovery from neuromuscular blockade
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis performed using the Intent-to-Treat (ITT) Population, which consisted of all treated subjects who had at least one efficacy measurement.

Reporting Groups

	Description
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.
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.

Measured Values

	Participants With Severe Renal Impairment	Participants With Normal Renal Function
Number of Participants Analyzed [units: participants]	35	32
Time to Recovery of the T4/T1 Ratio to 0.9. [units: seconds] Geometric Mean ( 95% Confidence Interval )	205 ( 169 to 248 )	112 ( 92 to 138 )

Statistical Analysis 1 for Time to Recovery of the T4/T1 Ratio to 0.9.

Groups ^[1]	All groups
Non-Inferiority/Equivalence Test ^[2]	Yes
Median Difference (Final Values) ^[3]	78.0
95% Confidence Interval	( 36.0 to 143.0 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	The 95% confidence interval for the estimated median treatment difference in recovery time must have fallen entirely within the pre-specified interval between -60 sec to +60 sec in order to claim equivalence
[3]	Other relevant estimation information:
	Estimated median treatment difference (severe renal impairment minus normal renal function) in recovery time (seconds)

2. Secondary:

Time to Recovery of the T4/T1 Ratio to 0.8 [ Time Frame: start of administration of sugammadex to recovery from neuromuscular blockade ]

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3. Secondary:

Time to Recovery of T4/T1 Ratio to 0.7 [ Time Frame: start of administration of sugammadex to recovery from neuromuscular blockade ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: All published results will be based on validated data released by the sponsor and must include one sponsor author. There may be one author from each investigational site, provided that the criteria for authorship are met. In case the proposed publication contains reference to an invention owned by sponsor or to which sponsor otherwise has rights, the sponsor may request a reasonable suspension of the publication in order to be able to file a patent application protecting such invention.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Vice President of Late Stage Development
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00702715 History of Changes
Other Study ID Numbers:	19.4.328, P05769
Study First Received:	June 19, 2008
Results First Received:	March 15, 2011
Last Updated:	March 15, 2011
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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