Status:
UNKNOWN
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)
Lead Sponsor:
Acologix, Inc.
Conditions:
Uremic Pruritus
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 18 yrs old or older
- moderate to severe pruritus
- end stage renal disease
- 3x weekly hemodialysis
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2011
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT00793156
Start Date
December 1 2009
End Date
March 1 2011
Last Update
February 4 2010
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