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: Other: Placebo; Drug: Nalfurafine HCl 2.5 µg; Drug: Nalfurafine HCl 5.0 µg

• 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

Study Timeline

• Study First Submitted: 2008-11-17
• Study First Submitted QC: 2008-11-17
• Study First Posted: 2008-11-19
• Study Start: 2009-12
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-03
• Last Update Posted: 2010-02-04
• Primary Completion: 2010-12
• Study Completion: 2011-03

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