Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Fixed-dose, Parallel-group, Multicenter, Efficacy, and Safety Study of MT-9938 for Treatment of Uremic Pruritus in Subjects With End-stage Renal Disease Receiving Hemodialysis
Brief Summary: This study is being conducted to investigate the efficacy of MT-9938 compared with placebo after 2 weeks, to continue to evaluate efficacy for an additional 6 weeks, and to explore the effect of a reduction in itching intensity on health-related Quality of Life(QoL) domains, especially those which recent research suggests have a positive correlation with overall survival for this patient group. The study will consist of the following phases: Screening (1 to 2 weeks), Run in (1 week), double-blind Treatment (8 weeks), Washout (1 week) culminating in a Follow-up Visit (1 week after the last dose).


Options:
A: Inclusion Criteria:

* hemodialysis patients that refered to dialysis centers and at least on hemodialysis thrice weekly
* presence of uremic pruritus
* patients that at least had refractive pruritus that lead to sleep disorders or compromised daily activities
* patients should took a course of antipruritic treatment with no proper response

Exclusion Criteria:

* presence of pruritus less than three months
* kt/V less than 1.2
* presence of pruritus due to other cause other than uremic state
* presence of other pruritic diseases; malignancies; cholestasis; hepatitis B and C infection
* treatment with corticosteroid
* presence of anemia with hemoglobin less than 10
B: Inclusion Criteria:

* On stable hemodialysis for at least 3 months
* Has stable functioning arteriovenous fistula, graft or other venous access
* Has continued (uncontrolled) uremic pruritus despite standard of care in the institution
* Has severe pruritus, as determined by a qualifying score of ≥3 on the Itch Severity Score Scale (0 to 4) either day or night during the week prior to Screening Visit
* Has no known drug addiction to any prescription, nonprescription, herbal or natural drugs, and successfully passes a drug screen test
* Women and men whose partners are of childbearing potential agree to practice the medically acceptable methods of birth control and agree to continue with the regimen throughout the duration of the study
* Capable of understanding and responding to the subject questionnaires, understands the purpose and risks of the study, and has given written informed consent
* Has rated his/her NRS score each day for at least 5 days out of the 7 days of the Run-in Phase
* Has severe pruritus, as determined by qualifying mean worst NRS score in a day of ≥5 (on 11 point NRS) at the end of the 1-week Run-in Phase

Exclusion Criteria:

* Current, clinically significant medical comorbidities
* Abnormal liver dysfunction
* Pruritus attributed mainly to any disease unrelated to kidney disease
* Calcium x phosphorus product \>80 mg2/dL2 or hemoglobin \<7 g/dL or parathyroid hormone levels \>1000 pg/mL at Screening
* Received ultraviolet B treatment within 30 days prior to Screening
* Started or changed psychotropic medication within 14 days prior to Screening
* Is receiving opioid antagonists or opioid agonists within 7 days prior to Screening and not willing to abstain from these medications during the study.
* Started or changed medications, creams or emollients including over-the-counter oil bath treatment for relief of pruritus within 7 days prior to Screening
* Has known hypersensitivity to opioids or the study drug ingredients
* Is currently participating in an investigational drug or device clinical study or was participating in such a study within 30 days prior to the start of Screening
* Female subject who is known to be pregnant or nursing
* Is considered not suitable for inclusion in the study in the opinion of Investigator
* Has current suicidal ideation with some intent to act or with specific plan and intent or had suicidal behavior at any time in subject's life
C: Inclusion Criteria:

* Willingness to sign an informed consent
* Stable haemodialysis treatment for more than 3 months, undergoing 2 to 3 times haemodialysis a week for 4 to 5 hours per session
* middle or large molecules retention defined as immunoreactive parathyroid hormone (iPTH) \> 400 pg/mL, β2MG\>5000 pg/ml、CRP\>10mg/l.
* Refractory pruritus, carpal tunnel syndrome, restless leg syndrome, hyperparathyroidism or other refratory complications.

Exclusion Criteria:

* Incapable or reluctant to sign the informed consent or comply the schedule.
* platelet (PLT) count\<60×109/L or disturbance in coagulation, tendency of severe bleeding or acute bleeding.
* Severe hypotension and heart or lung insufficiency
* Known hypersensitive or contradiction or intolerance to dialyzer or adsorbents
* Attend to other clinic trial now or in recent 30 days
D: Inclusion Criteria:

1. Age over 19 years
2. Patients with adequate HD (Kt/V \> 1.2)
3. Maintenance patients undergoing HD with chronic pruritus
4. Mean visual analog scale (VAS) over 4 of the last 5 days in the 14-day pre-observation period
5. Participants who allowed to continue the anti-pruritic drug treatment at the same dosage and administration schedule as used at baseline throughout the study period
6. Patients who agreed to participate in this trial and had written an informed consent

Exclusion Criteria:

1. Intact parathyroid hormone (iPTH) \> 1000 pg/mL within 1 month
2. Serum potassium \> 7.0 mg/dL
3. HIV Ab (+)
4. Aspartate transaminase (AST) (glutamic oxaloacetic transaminase) or alanine transaminase (ALT) (glutamic pyruvic transaminase) \> 3 times the upper limit of normal
5. Scheduled to have kidney transplantation within 3 months
6. Cancer history with current treatment
7. Active infection with current treatment
8. Current itching with dermatologic diseases other than uremic pruritus
9. Pregnancy, childbearing potential during the study period, or breastfeeding
10. Allergy or hypersensitivity reaction to PG102P
11. History of participating another clinical trial within 2 months or planning to participate another clinical trial
12. Not eligible to participate this trial as researchers' decision

Answer: B