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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)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2010 by Acologix, Inc..
Recruitment status was:  Not yet recruiting
ClinicalTrials.gov Identifier:
First Posted: November 19, 2008
Last Update Posted: February 4, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Acologix, Inc.
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 Intervention Phase
Uremic Pruritus Drug: Nalfurafine HCl 2.5 µg Drug: Nalfurafine HCl 5.0 µg Other: Placebo Phase 3

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:

Further study details as provided by Acologix, Inc.:

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. [ Time Frame: 11 weeks ]

Estimated Enrollment: 350
Study Start Date: December 2009
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
No Contacts or Locations Provided
  More Information

Responsible Party: Dawn McGuire, MD, Acologix, Inc
ClinicalTrials.gov Identifier: NCT00793156     History of Changes
Other Study ID Numbers: AC120-8231
First Submitted: November 17, 2008
First Posted: November 19, 2008
Last Update Posted: February 4, 2010
Last Verified: February 2010

Keywords provided by Acologix, Inc.:
uremic pruritus

Additional relevant MeSH terms:
Skin Diseases
Skin Manifestations
Signs and Symptoms