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)

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00793156

Acronym

AC120-8231

Enrollment

350

Registered

2008-11-19

Start date

2009-12-31

Completion date

2011-03-31

Last updated

2010-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uremic Pruritus

Keywords

uremic pruritus

Brief 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.

Interventions

DRUGNalfurafine HCl 2.5 µg

Daily dose of 2.5 µg

DRUGNalfurafine HCl 5.0 µg

Daily dose of 5.0 µg

OTHERPlacebo

Placebo daily dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Primary efficacy endpoint is the change in worst itching intensity from baseline, compared to that in the last two weeks of the double blind, placebo controlled, randomized withdrawal period.	11 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026