Trial | NCT00793156  Report issue

Title

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)

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    winfuran ...

  • Study Participants

    350
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 Started
Dec 31
2009
Primary Completion
Dec 31
2010
Anticipated
Study Completion
Mar 31
2011
Anticipated
Last Update
Feb 04
2010
Estimate

Drug Nalfurafine HCl 2.5 µg

Daily dose of 2.5 µg

Drug Nalfurafine HCl 5.0 µg

Daily dose of 5.0 µg

Other Placebo

Placebo daily dose

Placebo Placebo Comparator

Patients will be randomized into Placebo group

2 Active Comparator

2.5 µg group randomized

3 Active Comparator

5.0 µg group randomized

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
No Results Posted