Please select the eligibility criteria that correspond to the clinical trial below.
Title: Treatment of Uremic Pruritus With Inhaled PA101B in Patients With End-Stage Renal Disease Requiring Hemodialysis
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.


Options:
A: 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
B: Inclusion Criteria:

* Hemodialysis patients
* Suffering from pruritus for at least 6 weeks
* Have not responded to other drugs

Exclusion Criteria:

* Dermatological disease
* Liver disease
* Metabolic disease
C: Inclusion Criteria:

* Subject has been receiving in-center hemodialysis for ≥ 3 months and are currently on a schedule of 3 times a week.
* Subject self-categorized themselves on the Patient Assessed Disease Severity Scale during Screening
* Subject meets standard of care hemodialysis efficiency guidelines during the three months prior to completing Screening
* Have demonstrated pruritus intensity on the Itch NRS during screening
* Male or female who are at least 18 years old at the time of Screening

Exclusion Criteria:

* Subject had a significant alteration in dialysis regimen during the Screening Period
* Subject receiving or anticipated to be receiving nocturnal dialysis or home hemodialysis treatment during the study.
* Subject has pruritus that is believed to be caused by a condition unrelated to end-stage renal disease
* Has had a history of substance abuse within 6 months prior to completing Screening
* Subject has a known drug allergy to opioids
* Subject is a pregnant or lactating female.
D: Inclusion Criteria:

* Hemodialysis patients
* Suffering from pruritus for at least 6 weeks
* Have not responded to other drugs
* visual analogue scale (VAS) equal or more than 4

Exclusion Criteria:

* Liver disease
* Respiratory disease
* Dermatological disease
* Hemoglobin less than 10
* Cholestasis
* Malignancies

Answer: A