Ignite Creation Date:
2024-05-06 @ 8:12 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02696499
Status:
COMPLETED
Last Update Posted:
2018-04-20
First Post:
2016-02-25
Brief Title:
Treatment of Uremic Pruritus With PA101B
Sponsor:
Patara Pharma
Organization:
Patara Pharma
Study Overview
Official Title:
Treatment of Uremic Pruritus With Inhaled PA101B in Patients With End-Stage Renal Disease Requiring Hemodialysis
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized double blind placebo-controlled parallel-arm multi-center Phase 2 proof-of-concept efficacy and safety study in patients with end-stage renal disease requiring hemodialysis
The purpose of the study is to determine the efficacy and safety profile of PA101B delivered via eFlow high efficiency nebulizer in patients with uremic pruritus who are symptomatic despite using standard treatments
The purpose of the study is to determine the efficacy and safety profile of PA101B delivered via eFlow high efficiency nebulizer in patients with uremic pruritus who are symptomatic despite using standard treatments
Detailed Description:
The symptom score for determining eligibility will be established during the Screening Period up to 4 weeks and eligible patients will be randomly allocated in a 21 ratio between the active and placebo arms at the baseline visit Week 0 During the Treatment Period clinic visits will occur at the end of Weeks 1 3 5 and 7 Following completion of the Treatment Period patients will enter a 2-week Washout Period in both treatment arms
Routine hemodialysis treatment will continue according to the dialysis units standard practice in all patients
Patients will be allowed to continue to use the same daily doses of pre-randomization H1 antihistamines as well as the same daily doses of any other allowed medications throughout the study
Blood samples will be collected for various biomarkers In a subset of patients additional blood samples will be collected for pharmacokinetic assessments Clinical safety assessments will be performed at each clinic visit
Routine hemodialysis treatment will continue according to the dialysis units standard practice in all patients
Patients will be allowed to continue to use the same daily doses of pre-randomization H1 antihistamines as well as the same daily doses of any other allowed medications throughout the study
Blood samples will be collected for various biomarkers In a subset of patients additional blood samples will be collected for pharmacokinetic assessments Clinical safety assessments will be performed at each clinic visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None