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Uremic Pruritus | 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 research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Uremic Pruritus

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Nalfurafine HCl 2.5 µgDaily dose of 2.5 µg

Drug:Nalfurafine HCl 5.0 µgDaily dose of 5.0 µg

Other:PlaceboPlacebo daily dose

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

PlaceboPatients will be randomized into Placebo group

22.5 µg group randomized

35.0 µg group randomized

Study Status

Unknown status

Start Date: December 2009

Completed Date: March 2011

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: 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.

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Acologix, Inc.

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00793156

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