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| ID | Type | Description | Link |
|---|---|---|---|
| 19.4.304 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal renal function | Active Comparator | Org 25969 given to subjects with normal renal function |
|
| Impaired renal function | Experimental | Org 25969 given to subjects with impaired renal function |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.9 | After surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.7 and 0.8 | After surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20007792 | Derived | 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. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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|
| D003912 |
| Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |