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)

Acologix, Inc.350 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

350

Conditions

Uremic Pruritus

Interventions

Nalfurafine HCl 2.5 µgDRUG

Daily dose of 2.5 µg

Nalfurafine HCl 5.0 µgDRUG

Daily dose of 5.0 µg

PlaceboOTHER

Placebo daily dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 11 weeks

Data from ClinicalTrials.gov

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