A Randomized-Withdrawal Phase 3 Study Evaluating the Safety and Efficacy of Oral Nalfurafine HCl (AC-820)in Subjects on Hemodialysis With Uremic Pruritus (Renal Itch)
NCT ID: NCT00793156
Last Updated: 2010-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
350 participants
INTERVENTIONAL
2009-12-31
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Patients will be randomized into Placebo group
Placebo
Placebo daily dose
2
2.5 µg group randomized
Nalfurafine HCl 2.5 µg
Daily dose of 2.5 µg
3
5.0 µg group randomized
Nalfurafine HCl 5.0 µg
Daily dose of 5.0 µg
Interventions
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Nalfurafine HCl 2.5 µg
Daily dose of 2.5 µg
Nalfurafine HCl 5.0 µg
Daily dose of 5.0 µg
Placebo
Placebo daily dose
Eligibility Criteria
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Inclusion Criteria
* moderate to severe pruritus
* end stage renal disease
* 3x weekly hemodialysis
Exclusion Criteria
* abnormal liver function
* Ca-P \> 80 mg/dl or HgB \<8.5 g/dl or PTH \> pg/mL
* Within four months spKt/V \< 1.05
18 Years
80 Years
ALL
No
Sponsors
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Acologix, Inc.
INDUSTRY
Responsible Party
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Acologix, Inc
References
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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.
Other Identifiers
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AC120-8231
Identifier Type: -
Identifier Source: org_study_id
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