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) - Full Text View

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)

This study is not yet open for participant recruitment.

Verified by Acologix, Inc., November 2008

Sponsored by:	Acologix, Inc.
Information provided by:	Acologix, Inc.
ClinicalTrials.gov Identifier:	NCT00793156

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 III

MedlinePlus related topics: Dialysis Itching Kidney Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
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)

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:	June 2009
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator Patients will be randomized into Placebo group	Other: Placebo Placebo daily dose
2: Active Comparator 2.5 µg group randomized	Drug: Nalfurafine HCl 2.5 µg Daily dose of 2.5 µg
3: Active Comparator 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

Responsible Party:	Acologix, Inc ( Dawn McGuire, MD )
Study ID Numbers:	AC120-8231
Study First Received:	November 17, 2008
Last Updated:	November 17, 2008
ClinicalTrials.gov Identifier:	NCT00793156
Health Authority:	United States: Food and Drug Administration

Keywords provided by Acologix, Inc.:

uremic pruritus

Study placed in the following topic categories:

Pruritus
Signs and Symptoms
Skin Diseases

Additional relevant MeSH terms:

Skin Manifestations

ClinicalTrials.gov processed this record on January 15, 2009