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)
Phase 3
- Conditions
- Uremic Pruritus
- Interventions
- Registration Number
- NCT00793156
- Lead Sponsor
- Acologix, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 350
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo Patients will be randomized into Placebo group 2 Nalfurafine HCl 2.5 µg 2.5 µg group randomized 3 Nalfurafine HCl 5.0 µg 5.0 µg group randomized
- Primary Outcome Measures
Name Time Method 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. 11 weeks
- Secondary Outcome Measures
Name Time Method