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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014