NCT00793156.

Trial name or 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)
Methods	Multicentre, double‐blind, placebo‐controlled, randomised withdrawal study, cross‐over assignment
Participants	350 participants with moderate to severe itching associated with ESRD and haemodialysis
Interventions	Group 1: nalfurafine HCl 2.5 µg   Group 2: nalfurafine HCl 5.0 µg   Group 1: placebo
Outcomes	Primary efficacy endpoint is the change in worst itching intensity from baseline, compared to that in the last 2 weeks of the double blind, placebo‐controlled, randomised withdrawal period. Safety/efficacy study
Starting date	December 2009
Contact information	Acologix, Inc
Notes	The recruitment status of this study is unknown because the information has not been verified recently.