Clinical Trial: Treatment of Uremic Pruritus With PA101B

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Treatment of Uremic Pruritus With Inhaled PA101B in Patients With End-Stage Renal Disease Requiring Hemodialysis

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.


Detailed Summary:

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 2:1 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 unit's 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.


Sponsor: Patara Pharma

Current Primary Outcome: Itching intensity [ Time Frame: 7 weeks ]

Numerical rating scale (NRS)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pruritus-specific quality of life (QoL) [ Time Frame: 7 weeks ]
    Skindex-10
  • Pruritus-specific sleep quality [ Time Frame: 7 weeks ]
    Itch MOS
  • Assessment of depression [ Time Frame: 7 weeks ]
    Beck Depression Inventory-II
  • Patient Global Impression of Change (PGIC) [ Time Frame: 7 weeks ]


Original Secondary Outcome: Same as current

Information By: Patara Pharma

Dates:
Date Received: February 25, 2016
Date Started: February 2016
Date Completion:
Last Updated: April 5, 2017
Last Verified: April 2017