Treatment of Uremic Pruritus With PA101B

NCT ID: NCT02696499

Last Updated: 2018-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2016-12-31

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.

Conditions

Uremic Pruritus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

PA101B

Group Type: EXPERIMENTAL

PA101B

Intervention Type: DRUG

40 mg PA101B administered via inhalation twice daily for 7 weeks

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo administered via inhalation twice daily for 7 weeks

Interventions

PA101B

40 mg PA101B administered via inhalation twice daily for 7 weeks

Intervention Type: DRUG

Placebo

Matching placebo administered via inhalation twice daily for 7 weeks

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patara Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Arizona Kidney Disease and Hypertension Center

Phoenix, Arizona, United States

US Renal Care

Pine Bluff, Arkansas, United States

Valley Renal Medical Group

Northridge, California, United States

North America Research Institute

San Dimas, California, United States

Pines Clinical Research, Inc.

Pembroke Pines, Florida, United States

Genesis Clinical Research

Tampa, Florida, United States

Boise Kidney and Hypertension Institute

Meridian, Idaho, United States

Fresenius Medical Care of Evergreen Park

Evergreen Park, Illinois, United States

Renal Medicine Associates

Albuquerque, New Mexico, United States

US Renal Care

Gallup, New Mexico, United States

Ridgewood Dialysis Center

Ridgewood, New York, United States

Brookview Hills Research Associates LLC

Winston-Salem, North Carolina, United States

Southeast Renal Research Institute

Chattanooga, Tennessee, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33283264 (View on PubMed)

Other Identifiers

PA101B-UP-02

Identifier Type: -

Identifier Source: org_study_id