Phase 3
N=6
Dialysis of Sugammadex in Participants With Severe Renal Impairment (Study 19.4.333) (P05773)
Neuromuscular Blockade
Bottom Line
View on ClinicalTrials.gov: NCT00656799 ↗Enrolled (actual)
6
Serious AEs
33.3%
Results posted
Jul 2013
Primary outcome: Primary: Clearance of Sugammadex by Dialysis as Measured by the Reduction Ratio (RR) — 0.687; 0.566; 0.516; 0.532 Reduction Ratio
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- sugammadex (Drug); Rocuronium (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clearance of Sugammadex by Dialysis as Measured by the Reduction Ratio (RR) |
0.687; 0.566; 0.516; 0.532 | — |
| PRIMARY Clearance of Rocuronium by Dialysis as Measured by the Reduction Ratio (RR) |
0.750; 0.625; 0.521; 0.458 | — |
| PRIMARY Rate of Clearance of Sugammadex From Blood |
79.1; 76.5; 72.4; 83.4 | — |
| PRIMARY Rate of Clearance of Rocuronium From Blood |
80.2; 86.3; 94.1; 94.8 | — |
| PRIMARY Rate of Clearance of Sugammadex From Dialysate |
63.0; 65.1; 66.8 | — |
| PRIMARY Rate of Clearance of Rocuronium From Dialysate |
75.1; 97.2; 110; 95.3 | — |
| SECONDARY Number of Participants With Pre-treatment Adverse Events (AEs) |
1 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) |
2 | — |
| SECONDARY Number of Participants With Medical Device (Near) Incidents |
— | — |
| SECONDARY Vital Sign: Mean Systolic Blood Pressure |
124.2; 106.3; 105.5; 105.0; 103.2; 98.0 | — |
| SECONDARY Vital Sign: Mean Diastolic Blood Pressure |
58.2; 51.2; 45.2; 46.5; 44.5; 46.8 | — |
| SECONDARY Vital Sign: Mean Heart Rate |
81.7; 78.0; 83.7; 81.0; 80.5; 80.2 | — |
| SECONDARY Number of Participants With Physical Examinations |
6; 6; 0 | — |
| SECONDARY Number of Participants With Reoccurrence of Neuromuscular Blockade at Day 1 |
— | — |
| SECONDARY Number of Participants With Events Due to Possible Interaction of Sugammadex With Endo-/Exogenous Compounds Other Than Rocuronium |
— | — |
| SECONDARY Number of Participants With Pregnancies at 30 Days Post-dose |
— | — |
| SECONDARY Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.9 |
5.11 | — |
| SECONDARY Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.8 |
4.05 | — |
| SECONDARY Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.7 |
3.41 | — |
Summary
The clinical trial objectives were to evaluate the dialysability of the sugammadex-rocuronium complex; it's safety and efficacy in participants with severe renal impairment.
Eligibility Criteria
Inclusion Criteria
- At least 18 years of age
- American Society of Anesthesiologists (ASA) Class >=4
- Creatinine clearance (CLCR) < 30 mL/min and clinical indication for dialysis
- Hospitalization at Intensive Care Unit (ICU) and scheduled for a (surgical) procedure under general anesthesia requiring neuromuscular relaxation with the use of rocuronium
- Scheduled for a (surgical) procedure in supine position
- Written informed consent (of the legal representative)
Exclusion Criteria
- Known or suspected to have neuromuscular disorders impairing neuromuscular blockade and/or significant hepatic dysfunction
- Known or suspected to have a (family) history of malignant hyperthermia
- Known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia
- Have already participated in a sugammadex trial
- Have participated in another clinical trial, not preapproved by NV Organon, within 30 days of study entry
- Females who are pregnant*
- Females who are breast-feeding * In females pregnancy will be excluded both from medical history and by a human chorionic gonadotropin (hCG) test within 24 hours before surgery except in females who are not of childbearing potential, i.e. at least 2 years menopausal or have undergone tubal ligation or an hysterectomy.
Data sourced from ClinicalTrials.gov (NCT00656799). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.