NCT00793156View on ClinicalTrials.gov

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)

PHASE3UnknownINTERVENTIONAL
Enrollment

350

Participants

Timeline

Start Date

December 31, 2009

Primary Completion Date

December 31, 2010

Study Completion Date

March 31, 2011

Conditions
Uremic Pruritus
Interventions
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

Sponsors

Lead Sponsor

Acologix, Inc.
All Listed Sponsors
lead

Acologix, Inc.

INDUSTRY

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) | Biotech Hunter | Biotech Hunter