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 Unknown 350 enrolled Acologix, Inc.

RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start: 2009-12
Primary completion: 2010-12
Completion: 2011-03

Publications

Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Nalfurafine	Small molecule	2.5 ug	Oral
Comparator	Nalfurafine	Small molecule	5 ug	Oral

Indications

No indication recorded.