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)
AC120-8231
1 other identifier
interventional
350
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2009
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2008
CompletedFirst Posted
Study publicly available on registry
November 19, 2008
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedFebruary 4, 2010
February 1, 2010
1 year
November 17, 2008
February 3, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
Placebo
PLACEBO COMPARATORPatients will be randomized into Placebo group
2
ACTIVE COMPARATOR2.5 µg group randomized
3
ACTIVE COMPARATOR5.0 µg group randomized
Interventions
Eligibility Criteria
You may qualify if:
- yrs old or older
- moderate to severe pruritus
- end stage renal disease
- x weekly hemodialysis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Acologix, Inc.lead
Related Publications (1)
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.
PMID: 33283264DERIVED
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 17, 2008
First Posted
November 19, 2008
Study Start
December 1, 2009
Primary Completion
December 1, 2010
Study Completion
March 1, 2011
Last Updated
February 4, 2010
Record last verified: 2010-02