A single center, open-label trial in subjects with severe renal impairment evaluating the dialysability of the sugammadex-rocuronium complex

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-006934-33-BE

Enrollment

Registered

2008-01-03

Start date

2008-04-02

Completion date

Unknown

Last updated

2019-06-30

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

Conditions

None listed

Interventions

Product Name: sugammadex Product Code: Org 25969 Pharmaceutical Form: Solution for injection INN or Proposed INN: sugammadex CAS Number: 343306-79-6 Current Sponsor code: Org 25969 Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • At least 18 years of age • ASA Class = 4 • Creatinine clearance (CLCR) =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Subjects known or suspected to have neuromuscular disorders impairing neuromuscular blockade and/or significant hepatic dysfunction • Subjects known or suspected to have a (family) history of malignant hyperthermia • Subjects known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia • Subjects who have already participated in a sugammadex trial • Subjects who have participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into 19.4.333 • Female subjects who are pregnant* • Female subjects who are breast-feeding * In female subjects pregnancy will be excluded both from medical history and by an 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: • To evaluate the dialysability of the sugammadex-rocuronium complex in subjects with severe renal impairment • To evaluate the safety of sugammadex in subjects with severe renal impairment • To evaluate the efficacy of sugammadex in subjects with severe renal impairment ;Secondary Objective: ;Primary end point(s): • Dialysability of the sugammadex-rocuronium complex • Time from start of administration of sugammadex to recovery of the T4/T1 ratio to 0.9 • Time from start of administration of sugammadex to recovery of the T4/T1 ratio to 0.8 • Time from start of administration of sugammadex to recovery of the T4/T1 ratio to 0.7	—

Measure

Time frame

Main Objective: • To evaluate the dialysability of the sugammadex-rocuronium complex in subjects with severe renal impairment • To evaluate the safety of sugammadex in subjects with severe renal impairment • To evaluate the efficacy of sugammadex in subjects with severe renal impairment ;Secondary Objective: ;Primary end point(s): • Dialysability of the sugammadex-rocuronium complex • Time from start of administration of sugammadex to recovery of the T4/T1 ratio to 0.9 • Time from start of administration of sugammadex to recovery of the T4/T1 ratio to 0.8 • Time from start of administration of sugammadex to recovery of the T4/T1 ratio to 0.7

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Countries

Belgium

Outcome results