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 because the information has not been verified recently.
Verified February 2010 by Acologix, Inc..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Acologix, Inc.
ClinicalTrials.gov Identifier:
NCT00793156
First received: November 17, 2008
Last updated: February 3, 2010
Last verified: February 2010
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Dawn McGuire, MD, Acologix, Inc
ClinicalTrials.gov Identifier: NCT00793156     History of Changes
Other Study ID Numbers: AC120-8231
Study First Received: November 17, 2008
Last Updated: February 3, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Acologix, Inc.:
uremic pruritus

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

ClinicalTrials.gov processed this record on April 17, 2014