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)

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.

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