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Primary objective of this multicenter, double-blind, placebo controlled, randomized withdrawal study are to determine the effectiveness and safety of orally administered AC-820 in doses of 2.5 µg and 5.0 µg daily in patients with moderate to severe itching associated with end-stage renal disease and hemodialysis, and perform a population PK analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Patients will be randomized into Placebo group |
|
| 2 | Active Comparator | 2.5 µg group randomized |
|
| 3 | Active Comparator | 5.0 µg group randomized |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nalfurafine HCl 2.5 µg | Drug | Daily dose of 2.5 µg |
| |
| Nalfurafine HCl 5.0 µg |
| Measure | Description | Time Frame |
|---|---|---|
| Primary efficacy endpoint is the change in worst itching intensity from baseline, compared to that in the last two weeks of the double blind, placebo controlled, randomized withdrawal period. | 11 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33283264 | Derived | Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2. |
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| Drug |
Daily dose of 5.0 µg |
|
| Placebo | Other | Placebo daily dose |
|