E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
• 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
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• At least 18 years of age • ASA Class ≤ 4 • Creatinine clearance (CLCR) < 30 mL/min and clinical indication for dialysis • Hospitalization at 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)
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 7 |