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)

• Status: Unknown status
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Acologix, Inc.

Criteria

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