Treatment of Uremic Pruritus With PA101B
1 other identifier
interventional
70
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2016
Shorter than P25 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 25, 2016
CompletedFirst Posted
Study publicly available on registry
March 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedApril 20, 2018
April 1, 2018
6 months
February 25, 2016
April 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Itching intensity
Numerical rating scale (NRS)
7 weeks
Secondary Outcomes (4)
Pruritus-specific quality of life (QoL)
7 weeks
Pruritus-specific sleep quality
7 weeks
Assessment of depression
7 weeks
Patient Global Impression of Change (PGIC)
7 weeks
Study Arms (2)
PA101B
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Diagnosis of end-stage renal disease (ESRD) requiring hemodialysis for at least 3 months prior to the Screening Period
- Receiving conventional hemodialysis (i.e., not hemofiltration or hemodiafiltration)
- Pruritus present for at least 6 weeks of Screening
- Mean pruritus severity score on a numerical rating scale (NRS) \> 4
- Patient-Assessed Disease Severity Scale Type B or C at Screening
- Documentation of a urea reduction ratio (URR) \>65% or single-pooled Kt/V\> 1.4 during Screening
- Willing and able to provide written informed consent
You may not qualify if:
- Current or recent history of clinically significant medical condition, laboratory abnormality, or illness that could put the patient at risk or compromise the quality of the study data as determined by the investigator
- Myocardial infarction within 6 months or unstable angina, acute coronary syndrome, or interventional coronary procedure within 2 months of Screening
- Upper or lower respiratory tract infection (including sinus infection) within 4 weeks of Screening
- Severely symptomatic cardiopulmonary disease defined by the use of home oxygen treatment, dyspnea at rest or with minimal exertion, uncontrolled arrhythmias (e.g. atrial fibrillation with inadequate rate control), or history of life-threatening arrhythmias (e.g. cardiac arrest or syncope related to arrhythmia)
- Acute exacerbation of asthma or chronic obstructive pulmonary disease resulting in hospitalization or visit to an emergency department or urgent care clinic within 6 months of Screening
- Hospitalization for any medical reason other than for a pre-planned procedure or dialysis access related procedure within the 2 weeks of Screening
- Malignancy requiring active treatment with a systemic drug
- Participation in any other investigation drug study within 4 weeks of Screening
- Current or anticipated use of baclofen, gabapentin, pregabalin and nalbuphine for the treatment of pruritus
- Current or anticipated use of glucocorticoids administered intravenously, orally, or transdermally
- Pregnant or breastfeeding females, or if of child-bearing potential unwilling to practice acceptable means of birth control or abstinence during the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Patara Pharmalead
Study Sites (13)
Arizona Kidney Disease and Hypertension Center
Phoenix, Arizona, 85012, United States
US Renal Care
Pine Bluff, Arkansas, 71603, United States
Valley Renal Medical Group
Northridge, California, 91324, United States
North America Research Institute
San Dimas, California, 91773, United States
Pines Clinical Research, Inc.
Pembroke Pines, Florida, 33028, United States
Genesis Clinical Research
Tampa, Florida, 33614, United States
Boise Kidney and Hypertension Institute
Meridian, Idaho, 83642, United States
Fresenius Medical Care of Evergreen Park
Evergreen Park, Illinois, 60805, United States
Renal Medicine Associates
Albuquerque, New Mexico, 87109, United States
US Renal Care
Gallup, New Mexico, 87313, United States
Ridgewood Dialysis Center
Ridgewood, New York, 11385, United States
Brookview Hills Research Associates LLC
Winston-Salem, North Carolina, 27103, United States
Southeast Renal Research Institute
Chattanooga, Tennessee, 37408, United States
Related Publications (1)
Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
PMID: 33283264DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2016
First Posted
March 2, 2016
Study Start
February 1, 2016
Primary Completion
August 1, 2016
Study Completion
December 1, 2016
Last Updated
April 20, 2018
Record last verified: 2018-04