AnesthesiaPhase 3NCT00702715
Comparison of 4.0 mg/kg Sugammadex at 1-2 Post Tetanic Counts (PTC) in Renal or Control Patients (19.4.328)(P05769)
A Phase 3 study testing sugammadex in people with Anesthesia, run by Merck Sharp & Dohme LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- sugammadex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- 24 Sep 2008to 15 Mar 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- -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
Who cannot join
- 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
Show all 13Show fewer
- 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
About this study
Official title: 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.
Read the 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
- Being tested
- sugammadex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sugammadexDrug
Also called Org 25959
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: start of administration of sugammadex to recovery from neuromuscular blockade
Secondary outcomes (2)
Time to Recovery of the T4/T1 Ratio to 0.8
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.
Measured: start of administration of sugammadex to recovery from neuromuscular blockade
Time to Recovery of T4/T1 Ratio to 0.7
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.
Measured: start of administration of sugammadex to recovery from neuromuscular blockade
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2008 (estimated)
- Study start24 Sep 2008
- Primary completion15 Mar 2010
- Study completion15 Mar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00702715
- Sponsor's protocol ID
- P05769
- Other IDs
- 19.4.328
- Status last verified
- Apr 2017
- First submitted
- 19 Jun 2008
- Last updated
- 16 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 25829395
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00702715
- Acronym / sponsor ID
- P05769
- Conditions
- Anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2008 (actual)
- Primary completion
- 15 Mar 2010 (actual)
- Study completion
- 15 Mar 2010 (actual)
- First posted
- 20 Jun 2008 (estimated)
- Results
- Posted 11 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with severe renal impairment | Experimental | Drug: sugammadexParticipants 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 | Active comparator | Drug: sugammadexParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sugammadexAlso: Org 25959Each 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. | Drug | Participants with normal renal function, Participants with severe renal impairment |
Primary outcome
Time to Recovery of the T4/T1 Ratio to 0.9.
Time frame: start of administration of sugammadex to recovery from neuromuscular blockade
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.
2 secondary outcomes
Time to Recovery of the T4/T1 Ratio to 0.8
Time frame: start of administration of sugammadex to recovery from neuromuscular blockade
Time to Recovery of T4/T1 Ratio to 0.7
Time frame: start of administration of sugammadex to recovery from neuromuscular blockade
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25829395Panhuizen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sugammadex in people with Anesthesia, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Recovery of the T4/T1 Ratio to 0.9. (time frame: start of administration of sugammadex to recovery from neuromuscular blockade). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00702715, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2017.