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Treatment of Uremic Pruritus With PA101B

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02696499
Recruitment Status : Completed
First Posted : March 2, 2016
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Patara Pharma

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.


Condition or disease Intervention/treatment Phase
Uremic Pruritus Drug: PA101B Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Uremic Pruritus With Inhaled PA101B in Patients With End-Stage Renal Disease Requiring Hemodialysis
Study Start Date : February 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching

Arm Intervention/treatment
Experimental: PA101B Drug: PA101B
40 mg PA101B administered via inhalation twice daily for 7 weeks

Placebo Comparator: Placebo Drug: Placebo
Matching placebo administered via inhalation twice daily for 7 weeks




Primary Outcome Measures :
  1. Itching intensity [ Time Frame: 7 weeks ]
    Numerical rating scale (NRS)


Secondary Outcome Measures :
  1. Pruritus-specific quality of life (QoL) [ Time Frame: 7 weeks ]
    Skindex-10

  2. Pruritus-specific sleep quality [ Time Frame: 7 weeks ]
    Itch MOS

  3. Assessment of depression [ Time Frame: 7 weeks ]
    Beck Depression Inventory-II

  4. Patient Global Impression of Change (PGIC) [ Time Frame: 7 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02696499


Locations
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United States, Arizona
Arizona Kidney Disease and Hypertension Center
Phoenix, Arizona, United States, 85012
United States, Arkansas
US Renal Care
Pine Bluff, Arkansas, United States, 71603
United States, California
Valley Renal Medical Group
Northridge, California, United States, 91324
North America Research Institute
San Dimas, California, United States, 91773
United States, Florida
Pines Clinical Research, Inc.
Pembroke Pines, Florida, United States, 33028
Genesis Clinical Research
Tampa, Florida, United States, 33614
United States, Idaho
Boise Kidney and Hypertension Institute
Meridian, Idaho, United States, 83642
United States, Illinois
Fresenius Medical Care of Evergreen Park
Evergreen Park, Illinois, United States, 60805
United States, New Mexico
Renal Medicine Associates
Albuquerque, New Mexico, United States, 87109
US Renal Care
Gallup, New Mexico, United States, 87313
United States, New York
Ridgewood Dialysis Center
Ridgewood, New York, United States, 11385
United States, North Carolina
Brookview Hills Research Associates LLC
Winston-Salem, North Carolina, United States, 27103
United States, Tennessee
Southeast Renal Research Institute
Chattanooga, Tennessee, United States, 37408
Sponsors and Collaborators
Patara Pharma
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Patara Pharma
ClinicalTrials.gov Identifier: NCT02696499    
Other Study ID Numbers: PA101B-UP-02
First Posted: March 2, 2016    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Keywords provided by Patara Pharma:
Uremic pruritus
Pruritus
Chronic itch
Itch
Hemodialysis
End-stage renal disease
Additional relevant MeSH terms:
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Pruritus
Skin Diseases
Skin Manifestations