Uremic PruritusPhase 2NCT02696499
Treatment of Uremic Pruritus With PA101B
A Phase 2 study testing PA101B in people with Uremic Pruritus, run by Patara Pharma at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Uremic Pruritus
- What is being tested?
- PA101B
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 13 sitesUnited States
- Study dates
- Feb 2016to Dec 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Renal Medicine Associates
Albuquerque, New Mexico, 87109
Southeast Renal Research Institute
Chattanooga, Tennessee, 37408
Fresenius Medical Care of Evergreen Park
Evergreen Park, Illinois, 60805
US Renal Care
Gallup, New Mexico, 87313
Boise Kidney and Hypertension Institute
Meridian, Idaho, 83642
Valley Renal Medical Group
Northridge, California, 91324
Pines Clinical Research, Inc.
Pembroke Pines, Florida, 33028
Arizona Kidney Disease and Hypertension Center
Phoenix, Arizona, 85012
US Renal Care
Pine Bluff, Arkansas, 71603
Ridgewood Dialysis Center
Ridgewood, New York, 11385
North America Research Institute
San Dimas, California, 91773
Genesis Clinical Research
Tampa, Florida, 33614
Brookview Hills Research Associates LLC
Winston-Salem, North Carolina, 27103
About this study
Official title: 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.
Read the 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.
- Conditions
- Uremic Pruritus
- Being tested
- PA101B, Placebo
- Keywords
- Uremic pruritus, Pruritus, Chronic itch, Itch, Hemodialysis, End-stage renal disease
- Medical subject headings
- Pruritus, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PA101BDrug
40 mg PA101B administered via inhalation twice daily for 7 weeks
PlaceboDrug
Matching placebo administered via inhalation twice daily for 7 weeks
| Study group | Role | What they receive |
|---|---|---|
| PA101B | Experimental | Not described Receives: Drug: PA101B |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Itching intensity
Numerical rating scale (NRS)
Measured: 7 weeks
Secondary outcomes (4)
Pruritus-specific quality of life (QoL)
Skindex-10
Measured: 7 weeks
Pruritus-specific sleep quality
Itch MOS
Measured: 7 weeks
Assessment of depression
Beck Depression Inventory-II
Measured: 7 weeks
Patient Global Impression of Change (PGIC)
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionAug 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uremic PruritusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Patara Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02696499
- Sponsor's protocol ID
- PA101B-UP-02
- Status last verified
- Apr 2018
- First submitted
- 25 Feb 2016
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33283264
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Uremic Pruritus With Inhaled PA101B in Patients With End-Stage Renal Disease Requiring Hemodialysis
- ClinicalTrials.gov ID
- NCT02696499
- Acronym / sponsor ID
- PA101B-UP-02
- Conditions
- Uremic Pruritus
- Keywords
- Uremic pruritus, Pruritus, Chronic itch, Itch, Hemodialysis, End-stage renal disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Patara PharmaIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 2 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PA101B | Experimental | Drug: PA101B |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PA101B40 mg PA101B administered via inhalation twice daily for 7 weeks | Drug | PA101B |
| PlaceboMatching placebo administered via inhalation twice daily for 7 weeks | Drug | Placebo |
Primary outcome
Itching intensity
Time frame: 7 weeks
Numerical rating scale (NRS)
4 secondary outcomes
Pruritus-specific quality of life (QoL)
Time frame: 7 weeks
Pruritus-specific sleep quality
Time frame: 7 weeks
Assessment of depression
Time frame: 7 weeks
Patient Global Impression of Change (PGIC)
Time frame: 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
- Derived from this study: PubMed 33283264Hercz 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PA101B in people with Uremic Pruritus, run by Patara Pharma at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Itching intensity (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02696499, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2018; AzTrials last refreshed its copy on 7 Nov 2026.