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

A Multicenter, Parallel Group, Comparative Trial Evaluating the Efficacy, Pharmacokinetics and Safety of Org 25969 in Subjects With Normal or Impaired Renal Function

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00482599

Enrollment

Registered

2007-06-05

Start date

2005-06-01

Completion date

2006-04-13

Last updated

2017-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, General

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.

Interventions

DRUGSugammadex

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.9	After surgery

Secondary

Measure	Time frame
Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.7 and 0.8	After surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026