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Clinical Trials/NCT00793156
NCT00793156
Unknown
Phase 3

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)

Acologix, Inc.0 sites350 target enrollmentDecember 2009
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ConditionsUremic Pruritus
InterventionsPlaceboNalfurafine HCl 2.5 µgNalfurafine HCl 5.0 µg
DrugsNalfurafine HCl 2.5 µgNalfurafine HCl 5.0 µg

Overview

Phase
Phase 3
Intervention
Placebo
Conditions
Uremic Pruritus
Sponsor
Acologix, Inc.
Enrollment
350
Primary Endpoint
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.
Last Updated
16 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
December 2009
End Date
March 2011
Last Updated
16 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Eligibility 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

Arms & Interventions

Placebo

Patients will be randomized into Placebo group

Intervention: Placebo

2

2.5 µg group randomized

Intervention: Nalfurafine HCl 2.5 µg

3

5.0 µg group randomized

Intervention: Nalfurafine HCl 5.0 µg

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

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