Please select the eligibility criteria that correspond to the clinical trial below.
Title: Assessment of Montelukast Efficacy in the Treatment of Refractive Uremic Pruritus
Brief Summary: In this study hemodialysis patients that underwent dialysis thrice weekly screen for uremic pruritus and 80 patients that at least have refractive pruritus that lead to sleep and daily activity disorders enroll in this study. These patients should have at least a course of therapy without proper response. After proper informing patients and taking testimonial patients enter to study. Then patients randomized in case and control group. In case group, patients took montelukast 10 milligram daily and in control group took placebo for 30 days. Other antipruritic or antiinflammatory medication has been stopped one week prior to starting treatment. Calcium, phosphorous, urea, creatinine, highly sensitive CRP (hsCRP), Parathyroid Hormone (PTH), hemoglobin and kt/V were measured at beginning and at end of study. pruritus severity assessed by Detailed Pruritus Score that introduced by Duo and Visual Analogue Score in beginning and at end of study in both group. Sleep disorder score and its severity added to crude score at beginning and end of study and change of measures analyzed.


Options:
A: Inclusion Criteria:

1. Willing and able to provide written informed consent prior to participating in this study;
2. Able to communicate clearly with the Investigator and staff, able to read, complete questionnaires, and understand the study procedures;
3. Males or females 18 years of age or older;
4. ESRD patients who have been on hemodialysis 3 times per week for at least 3 months prior to the start of Screening;
5. Women of child-bearing potential must have a negative serum pregnancy test and agree to practice an acceptable form of birth control for the duration of the study
6. Male patients that are not biologically or surgically sterile must agree to practice an acceptable from of birth control for the duration of the study
7. Weigh between 88.2 lb (40.0 kg) and 297.6 lb (135.0 kg).
8. Patient must self-report pruritus in the month prior to screening.
9. If patient is receiving treatment for itch, this treatment must be stable prior to screening and during treatment period.
10. At least 2 single-pool Kt/V measurements ≥ 1.2, or at least 2 urea reduction ratio measurements ≥ 65%, or 1 single-pool Kt/V measurement ≥ 1.2 and 1 urea reduction ratio measurement ≥ 65% on different dialysis days during the 3 months period prior to Screening;
11. Patient who self-categorize as moderate-to-severe itch.

Exclusion Criteria:

1. Known to be non-compliant with dialysis treatment (i.e., has missed more than 2 dialysis sessions in the past 2 months because of non-compliance);
2. Anticipated to receive a kidney transplant during the study;
3. Known history of allergic reaction to opiates, such as hives
4. Known or suspected history of alcohol, narcotic, or other drug abuse or dependence within 12 months prior to Screening;
5. Patient has any clinically relevant acute or chronic medical or neuropsychiatric condition which, in the opinion of the Investigator, would pose undue risk to the patient, would impede completion of the study procedures, or would compromise the validity of the study measurements;
6. Serum alanine aminotransferase or aspartate aminotransferase greater than 2.5 times the reference upper limit of normal (ULN), or total bilirubin greater than 2 times ULN at Screening;
7. Received another investigational drug within 30 days prior to the start of Screening or has planned to participate in another clinical trial while enrolled in this study;
8. Has pruritus probably or definitely attributed to a cause other than ESRD or its complications (e.g., patients with concomitant pruritic dermatological disease or cholestatic liver disease would be excluded). (Note: Patients whose pruritus is attributed to ESRD complications such as hyperparathyroidism, hyperphosphatemia, anemia, or the dialysis procedure or prescription may be enrolled);
9. Has localized itch restricted to the palms of the hands;
10. Has pruritus only during the dialysis session (by patient report);
11. Anticipated to receive opioid antagonists (e.g., naloxone, naltrexone), or opioid mixed agonist-antagonist (e.g., buprenorphine, nalbuphine) from the start of Screening through the end of the Treatment Period;
12. Used Salvia divinorum or Salvinorin A within 30 days prior to the start of Screening or is anticipated to use it during the study;
13. Received ultraviolet B treatment within 30 days prior to the start of Screening or anticipated to receive such treatment during the study;
14. Participated in a previous clinical trial with CR845.
B: 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
C: 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
D: Inclusion Criteria:

* Male or female patients 18 years of age to 70 years of age.
* A diagnosis of moderate to severe pruritus.
* At least 3 episodes of itch over a period of 2 weeks, each lasting for 2 minutes or more.
* Symptoms of itch in regular pattern over 6 months.
* Itch Visual analog scale (VAS) of 3cm or more out of 10 cm.
* All subjects will be end stage renal failure patients undergoing hemodialysis for at least 3 months, who have substantial pruritus for more than 6 months. Substantial pruritus is defined as persistent pruritus impairing sleep or daytime activity.
* Ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study
* The ability to understand and sign a written informed consent form, which must be obtained prior to treatment.

Exclusion Criteria:

* Presence of infection (as defined by the investigator) on the area to be treated.
* Subjects with history of pruritus predating renal failure and subjects with skin disease unrelated to uremia, such as atopic dermatitis, will be excluded.
* Use of systemic medications for treatment of pruritus including corticosteroids within the past 4 weeks and during the study.
* Use of topical medications for treatment of pruritus, including corticosteroids, within the past week.
* Pregnant women, women who are breast feeding, or women of child bearing potential who are not practicing an acceptable method of birth control (abstinence, birth control pill/patch, barrier with spermicidal jelly, IUD, etc.), as determined by the investigator. Acceptable contraception must be used during the entire study.

Answer: C