Dialysis of Sugammadex in Participants With Severe Renal Impairment (Study 19.4.333) (P05773)

NCT00656799 | Completed Phase 3 Results

• 2 other identifiers: P057732007-006934-33
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Neuromuscular Blockade

Outcome Measures

Primary Outcomes (6)

• Clearance of Sugammadex by Dialysis as Measured by the Reduction Ratio (RR)

  Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected before, and after hemodialysis, with concentrations of sugammadex determined using a liquid chromatographic assay with mass spectrometric detection. The clearance of sugammadex at each dialysis session was calculated by measuring the ratio of plasma concentration at the end of dialysis, average duration of 6 hours, compared with that immediately before the start of dialysis, called the RR.

  Up to day 7

• Clearance of Rocuronium by Dialysis as Measured by the Reduction Ratio (RR)

  Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected before, and after hemodialysis, with concentrations of rocuronium determined using a liquid chromatographic assay with mass spectrometric detection. The clearance of rocuronium at each dialysis session was calculated by measuring the ratio of plasma concentration at the end of dialysis, average duration of 6 hours, compared with that immediately before the start of dialysis, called the RR.

  Up to Day 7

• Rate of Clearance of Sugammadex From Blood

  Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Blood samples were collected from ports in the arterial and venous tubing of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of sugammadex were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from blood at each dialysis session was assessed by averaging across all available collection time points.

  Up to day 7

• Rate of Clearance of Rocuronium From Blood

  Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Blood samples were collected from ports in the arterial and venous tubing of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of rocuronium were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from blood at each dialysis session was assessed by averaging across all available collection time points.

  Up to Day 7

• Rate of Clearance of Sugammadex From Dialysate

  Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected from a port in the outflow of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of sugammadex were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from dialysate at each dialysis session was assessed by averaging across all available collection time points.The data from the fourth dialysis are not presented as they were not calculable.

  Up to day 7

• Rate of Clearance of Rocuronium From Dialysate

  Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected from a port in the outflow of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of rocuronium were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from dialysate at each dialysis session was assessed by averaging across all available collection time points.

  Up to Day 7

Secondary Outcomes (13)

• Number of Participants With Pre-treatment Adverse Events (AEs)

  Screening up to Day 1

• Number of Participants With Serious Adverse Events (SAEs)

  Up to day 7

• Number of Participants With Medical Device (Near) Incidents

  Up to day 7

• Vital Sign: Mean Systolic Blood Pressure

  Screening up to 1 day after surgery

• Vital Sign: Mean Diastolic Blood Pressure

  Screening up to 1 day after surgery

Study Arms (1)

Sugammadex

EXPERIMENTAL

IV single bolus dose of 4.0 mg/kg sugammadex

Drug: sugammadex; Drug: Rocuronium

Interventions

sugammadex DRUG

At 15 minutes after administration of rocuronium, an IV single bolus dose of 4.0 mg/kg sugammadex was administered.

Also known as: Org 25969, SCH 900616, MK-8616, Bridion®

Sugammadex

Rocuronium DRUG

After achieving stable anesthesia an IV single bolus dose of 0.6 mg/kg rocuronium was administered

Also known as: Rocuronium bromide, Esmeron®

Sugammadex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Cammu G, Van Vlem B, van den Heuvel M, Stet L, el Galta R, Eloot S, Demeyer I. Dialysability of sugammadex and its complex with rocuronium in intensive care patients with severe renal impairment. Br J Anaesth. 2012 Sep;109(3):382-90. doi: 10.1093/bja/aes207. Epub 2012 Jun 24.

  PMID: 22732111 RESULT

MeSH Terms

Interventions

Sugammadex; Rocuronium

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Androstanols; Androstanes; Steroids; Fused-Ring Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2008
• First Posted: April 11, 2008
• Study Start: April 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: March 10, 2015
• Results First Posted: July 31, 2013

Record last verified: 2015-02