Back to resultsA 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) (AC120-8231)
Primary Purpose
Uremic Pruritus
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Nalfurafine HCl 2.5 µg
Nalfurafine HCl 5.0 µg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Uremic Pruritus focused on measuring uremic pruritus
Eligibility Criteria
Inclusion Criteria:
- 18 yrs old or older
- moderate to severe pruritus
- end stage renal disease
- 3x weekly hemodialysis
Exclusion Criteria:
- pruritus not due to renal disease
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Placebo
2
3
Arm Description
Patients will be randomized into Placebo group
2.5 µg group randomized
5.0 µg group randomized
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00793156
Brief Title
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)
Acronym
AC120-8231
Official Title
A Randomized-Withdrawal Phase 3 Study Evaluation the Safety and Efficacy of Oral Nalfurafine HCl (AC-820)in Subjects on Hemodialysis With Uremic Pruritus (Renal Itch)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
March 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Acologix, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uremic Pruritus
Keywords
uremic pruritus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
350 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will be randomized into Placebo group
Arm Title
2
Arm Type
Active Comparator
Arm Description
2.5 µg group randomized
Arm Title
3
Arm Type
Active Comparator
Arm Description
5.0 µg group randomized
Intervention Type
Drug
Intervention Name(s)
Nalfurafine HCl 2.5 µg
Intervention Description
Daily dose of 2.5 µg
Intervention Type
Drug
Intervention Name(s)
Nalfurafine HCl 5.0 µg
Intervention Description
Daily dose of 5.0 µg
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo daily dose
Primary Outcome Measure Information:
Title
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.
Time Frame
11 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 yrs old or older
moderate to severe pruritus
end stage renal disease
3x weekly hemodialysis
Exclusion Criteria:
pruritus not due to renal disease
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
33283264
Citation
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.
Results Reference
derived
Learn more about this trial
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)
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