Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized-Withdrawal Phase 3 Study Evaluation the Safety and Efficacy of Oral Nalfurafine HCl (AC-820)in Subjects on Hemodialysis With Uremic Pruritus (Renal Itch)
Brief Summary: Primary objective of this multicenter, double-blind, placebo controlled, randomized withdrawal study are to determine the effectiveness and safety of orally administered AC-820 in doses of 2.5 µg and 5.0 µg daily in patients with moderate to severe itching associated with end-stage renal disease and hemodialysis, and perform a population PK analysis.


Options:
A: 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
B: Inclusion Criteria:

* 18 yrs old or older
* moderate to severe pruritus
* end stage renal disease
* 3x weekly hemodialysis

Exclusion Criteria:

* pruritus not due to renal disease
* abnormal liver function
* Ca-P \> 80 mg/dl or HgB \<8.5 g/dl or PTH \> pg/mL
* Within four months spKt/V \< 1.05
C: Inclusion Criteria:

* Patients who have end-stage renal disease (ESRD) on maintenance hemodialysis more than twice weekly for at least three months and suffered from uremic pruritus.
* 20 Years and older
* Definition of uremic pruritus:

Patients were considered to have pruritus if they had either of the following conditions:

* at least 3 episodes of itch during a period of 2 weeks or less, with the symptom appearing a few times a day, lasting at least a few minutes, and troubling the patient
* he appearance of an itch in a regular pattern during a period of 6 months, but less frequently than listed above.

To be defined as "uremic," the pruritus had to appear shortly before the onset of dialysis, or at any time after that, without evidence of any other active disease that could explain the pruritus.

-Patients who suffer from severe pruritus unresponsive to topical emollient and corticosteroids, and were diagnosed as having uremic pruritus by dermatologists

Exclusion Criteria:

1. All patients with pruritus attributable to any other causes, such as scabies or other evident skin diseases (atopic dermatitis, psoriasis, generalized dermatitis, pediculosis, urticaria ...etc), and any medication with potential pruritic properties.
2. Patients whose pruritus occurred only during dialysis
3. Patients received oral drugs with presumed antipruritic effect, including benzodiazepines, muscle relaxants, opioid analgesics, tricyclic antidepressants and antiepileptic drugs, or ultraviolet B phototherapy in the past one week prior to participate in this trial or during the trial.
4. Concomitant elevation of liver enzymes (GOT: male \>37 U/L, female:\>31 U/L, GPT: male \>41 U/L, female:\>31U/L), alkaline phosphatase (ALP\>104U/L), bilirubin (T-bil\>1.2 mg/dL), serum phosphorus (\>7 mg/dl), serum parathyroid hormone (\>300 pg/ml).
5. Patients who have the history of allergy to pregabalin, any acute illness, liver cirrhosis, hepatic failure, decompensated heart failure, inability to give informed consent, or poor compliance.
6. Patients with uncontrolled psychiatric disease, active malignancy, and untreated hypothyroidism.
7. Female patients who are pregnant, are nursing, or want to become pregnant.
D: Inclusion Criteria:

* Hemodialysis patients \> 18 yo suffering from pruritus for at least 6 weeks, and who have not responded to other drugs
* Willing and able to give informed concent

Exclusion Criteria:

* Known dermatologic, liver, metabolic disease, or any other disease or condition other than ESRD that causes pruritus
* Lactase deficiency

Answer: B