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) (AC120-8231)

Acologix

Status and phase: Unknown; Phase 3

Conditions: Uremic Pruritus

Treatments: Drug: Nalfurafine HCl 2.5 µg; Drug: Nalfurafine HCl 5.0 µg; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00793156

AC120-8231

Details and patient eligibility

About

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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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350 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Patients will be randomized into Placebo group

Treatment:

Other: Placebo

2

Active Comparator group

Description:

2.5 µg group randomized

Treatment:

Drug: Nalfurafine HCl 2.5 µg

3

Active Comparator group

Description:

5.0 µg group randomized

Treatment:

Drug: Nalfurafine HCl 5.0 µg