Dialysis of Sugammadex in Participants With Severe Renal Impairment (Study 19.4.333) (P05773)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neuromuscular Blockade
Intervention: sugammadex (Drug); Rocuronium (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp.
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.
Clinical Details
Official title: A Single Center, Open-Label Trial in Subjects With Severe Renal Impairment Evaluating the Dialysability of the Sugammadex-Rocuronium Complex
Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Clearance of Sugammadex by Dialysis as Measured by the Reduction Ratio (RR)Clearance of Rocuronium by Dialysis as Measured by the Reduction Ratio (RR) Rate of Clearance of Sugammadex From Blood Rate of Clearance of Rocuronium From Blood Rate of Clearance of Sugammadex From Dialysate Rate of Clearance of Rocuronium From Dialysate
Secondary outcome: Number of Participants With Pre-treatment Adverse Events (AEs)Number of Participants With Serious Adverse Events (SAEs) Number of Participants With Medical Device (Near) Incidents Vital Sign: Mean Systolic Blood Pressure Vital Sign: Mean Diastolic Blood Pressure Vital Sign: Mean Heart Rate Number of Participants With Physical Examinations Number of Participants With Reoccurrence of Neuromuscular Blockade at Day 1 Number of Participants With Events Due to Possible Interaction of Sugammadex With Endo-/Exogenous Compounds Other Than Rocuronium Number of Participants With Pregnancies at 30 Days Post-dose Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.9 Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.8 Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.7
Detailed description:
The current trial was designed to evaluate the dialysability of the sugammadex-rocuronium
complex in participants with severe renal impairment. A dose of 4. 0 mg/kg sugammadex was
administered 15 minutes after administration of 0. 6 mg/kg rocuronium. Blood and dialysate
samples were collected before, during and after hemodialysis/filtration, for calculation of
clearance of sugammadex-rocuronium complex and assessment of rebound.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: April 2008
Last updated: February 20, 2015
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