Efficacy, Pharmacokinetics and Safety of Org 25969 in Subjects With Normal or Impaired Renal Function (19.4.304)(P05948)(COMPLETED)

NCT00482599 | Completed Phase 3

• 2 other identifiers: P0594819.4.304
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the efficacy and pharmacokinetics of Org 25969 in subjects with normal or impaired renal function and to evaluate the safety of Org 25969 in subjects with impaired renal function.

Conditions

Anesthesia, General

Outcome Measures

Primary Outcomes (1)

• Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.9

  After surgery

Secondary Outcomes (1)

• Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.7 and 0.8

  After surgery

Study Arms (2)

Normal renal function

ACTIVE COMPARATOR

Org 25969 given to subjects with normal renal function

Drug: Sugammadex

Impaired renal function

EXPERIMENTAL

Org 25969 given to subjects with impaired renal function

Drug: Sugammadex

Interventions

Sugammadex DRUG

2 mg/kg sugammadex administered intravenously at reappearance of T2 after 0.6 mg/kg rocuronium in patients with renal impairment and control patients

Also known as: Org 25969

Impaired renal function; Normal renal function

Eligibility Criteria

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

You may qualify if:

• ASA class 1 - 3 for renally impaired patients, ASA class 1-2 for control group
• Age at least 18 years
• Scheduled for general anesthesia without further need for muscle relaxation other than one single dose of 0.6 mg.kg-1 rocuronium
• Scheduled for surgical procedures in the supine position
• Written informed consent
• Creatinine clearance (CLCR) \< 30 mL/min for renally impaired group, CLCR = 80 mL/min for control group

You may not qualify if:

• Known or suspected neuromuscular disorders impairing NMB
• Known or suspected (family) history of malignant hyperthermia
• Known or suspected allergy to narcotics, muscle relaxants or other medication used during general anesthesia
• Use of medication known to interfere with NMBA based on the dose and the time of administration, such as antibiotics, anticonvulsants and Mg2+
• Pregnancy
• Childbearing potential without using any of the following methods of birth control: condom or diaphragm with spermicide, vasectomized partner ( \> 6 months), intrauterine device, abstinence
• Breast-feeding
• Prior participation in any trial with Org 25969
• Participation in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into trial 19.4.304, or for the UK only: Participation in another clinical trial, within 30 days of entering into trial 19.4.304.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Staals LM, Snoeck MM, Driessen JJ, van Hamersvelt HW, Flockton EA, van den Heuvel MW, Hunter JM. Reduced clearance of rocuronium and sugammadex in patients with severe to end-stage renal failure: a pharmacokinetic study. Br J Anaesth. 2010 Jan;104(1):31-9. doi: 10.1093/bja/aep340.

  PMID: 20007792 DERIVED

MeSH Terms

Interventions

Sugammadex

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2007
• First Posted: June 5, 2007
• Study Start: June 1, 2005
• Primary Completion: April 13, 2006
• Study Completion: April 13, 2006
• Last Updated: June 16, 2017

Record last verified: 2017-06