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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)

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ClinicalTrials.gov Identifier: NCT00793156
Recruitment Status : Unknown
Verified February 2010 by Acologix, Inc..
Recruitment status was:  Not yet recruiting
First Posted : November 19, 2008
Last Update Posted : February 4, 2010
Sponsor:
Information provided by:
Acologix, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Uremic Pruritus Drug: Nalfurafine HCl 2.5 µg Drug: Nalfurafine HCl 5.0 µg Other: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : December 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Patients will be randomized into Placebo group
 Other: Placebo
Placebo daily dose
Active Comparator: 2
2.5 µg group randomized
 Drug: Nalfurafine HCl 2.5 µg
Daily dose of 2.5 µg
Active Comparator: 3
5.0 µg group randomized
 Drug: Nalfurafine HCl 5.0 µg
Daily dose of 5.0 µg


Outcome Measures
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Primary Outcome Measures :
  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. [ Time Frame: 11 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dawn McGuire, MD, Acologix, Inc
ClinicalTrials.gov Identifier: NCT00793156    
Other Study ID Numbers: AC120-8231
First Posted: November 19, 2008    Key Record Dates
Last Update Posted: February 4, 2010
Last Verified: February 2010
Keywords provided by Acologix, Inc.:
uremic pruritus
Additional relevant MeSH terms:
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Pruritus
Skin Diseases
Skin Manifestations