Treatment of Uremic Pruritus With PA101B



Status:Completed
Conditions:Allergy, Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology, Otolaryngology
Healthy:No
Age Range:18 - 80
Updated:4/22/2018
Start Date:February 2016
End Date:December 2016

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

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 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.

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
We found this trial at
13
sites
Chattanooga, Tennessee 37404
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Chattanooga, TN
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Pembroke Pines, Florida 33028
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Pembroke Pines, FL
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Albuquerque, New Mexico 87109
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Albuquerque, NM
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Evergreen Park, Illinois 60805
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Evergreen Park, IL
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Gallup, New Mexico 87313
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Gallup, NM
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from
Meridian, ID
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Northridge, California 91324
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Northridge, CA
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Phoenix, AZ
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Pine Bluff, Arkansas 76103
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from
Pine Bluff, AR
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Ridgewood, New York 11385
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Ridgewood, NY
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San Dimas, California 91773
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from
San Dimas, CA
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Tampa, Florida 33614
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from
Tampa, FL
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Winston-Salem, North Carolina 27103
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from
Winston-Salem, NC
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