NCT00793156

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)

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)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Acologix, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Uremic Pruritus

Interventions

Type	Name	Description
DRUG	Nalfurafine HCl 2.5 µg	Daily dose of 2.5 µg
DRUG	Nalfurafine HCl 5.0 µg	Daily dose of 5.0 µg
OTHER	Placebo	Placebo daily dose

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-12-01
• Completion: 2011-03-01
• First posted: 2008-11-19
• Last updated: 2010-02-04