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Treatment of Uremic Pruritus With PA101B

Primary Purpose

Uremic Pruritus

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PA101B
Placebo
Sponsored by
Patara Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uremic Pruritus focused on measuring Uremic pruritus, Pruritus, Chronic itch, Itch, Hemodialysis, End-stage renal disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Arizona Kidney Disease and Hypertension Center
  • US Renal Care
  • Valley Renal Medical Group
  • North America Research Institute
  • Pines Clinical Research, Inc.
  • Genesis Clinical Research
  • Boise Kidney and Hypertension Institute
  • Fresenius Medical Care of Evergreen Park
  • Renal Medicine Associates
  • US Renal Care
  • Ridgewood Dialysis Center
  • Brookview Hills Research Associates LLC
  • Southeast Renal Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PA101B

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Itching intensity
Numerical rating scale (NRS)

Secondary Outcome Measures

Pruritus-specific quality of life (QoL)
Skindex-10
Pruritus-specific sleep quality
Itch MOS
Assessment of depression
Beck Depression Inventory-II
Patient Global Impression of Change (PGIC)

Full Information

First Posted
February 25, 2016
Last Updated
April 18, 2018
Sponsor
Patara Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT02696499
Brief Title
Treatment of Uremic Pruritus With PA101B
Official Title
Treatment of Uremic Pruritus With Inhaled PA101B in Patients With End-Stage Renal Disease Requiring Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Patara Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uremic Pruritus
Keywords
Uremic pruritus, Pruritus, Chronic itch, Itch, Hemodialysis, End-stage renal disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PA101B
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PA101B
Intervention Description
40 mg PA101B administered via inhalation twice daily for 7 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo administered via inhalation twice daily for 7 weeks
Primary Outcome Measure Information:
Title
Itching intensity
Description
Numerical rating scale (NRS)
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Pruritus-specific quality of life (QoL)
Description
Skindex-10
Time Frame
7 weeks
Title
Pruritus-specific sleep quality
Description
Itch MOS
Time Frame
7 weeks
Title
Assessment of depression
Description
Beck Depression Inventory-II
Time Frame
7 weeks
Title
Patient Global Impression of Change (PGIC)
Time Frame
7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Arizona Kidney Disease and Hypertension Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
US Renal Care
City
Pine Bluff
State/Province
Arkansas
ZIP/Postal Code
71603
Country
United States
Facility Name
Valley Renal Medical Group
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
North America Research Institute
City
San Dimas
State/Province
California
ZIP/Postal Code
91773
Country
United States
Facility Name
Pines Clinical Research, Inc.
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Genesis Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Boise Kidney and Hypertension Institute
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Fresenius Medical Care of Evergreen Park
City
Evergreen Park
State/Province
Illinois
ZIP/Postal Code
60805
Country
United States
Facility Name
Renal Medicine Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
US Renal Care
City
Gallup
State/Province
New Mexico
ZIP/Postal Code
87313
Country
United States
Facility Name
Ridgewood Dialysis Center
City
Ridgewood
State/Province
New York
ZIP/Postal Code
11385
Country
United States
Facility Name
Brookview Hills Research Associates LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Southeast Renal Research Institute
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37408
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33283264
Citation
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.
Results Reference
derived

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Treatment of Uremic Pruritus With PA101B

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