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)

Uremic Pruritus Clinical Trial

— AC120-8231  

Official title:

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00793156
• Other study ID #: AC120-8231
• Status: Not yet recruiting
• Phase: Phase 3
• First received: November 17, 2008
• Last updated: February 3, 2010
• Start date: December 2009
• Est. completion date: March 2011

Study information

• Verified date: February 2010
• Source: Acologix, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: March 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pruritus
• Uremic Pruritus

Intervention

Drug:
• Nalfurafine HCl 2.5 µg
Daily dose of 2.5 µg
• Nalfurafine HCl 5.0 µg
Daily dose of 5.0 µg

Other:
• Placebo
Placebo daily dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Acologix, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes