To Evaluate the Efficacy and Safety of Nemolizumab for 12 Weeks in Participants With Chronic Kidney Disease With Associated Moderate to Severe Pruritus

Inclusion Criteria

• Participants aged >= 18 years at the screening visit.
• Had end-stage kidney disease (ESKD) and had been on hemodialysis three times per week for at least three months prior to the start of screening.

Note 1: Participants who required an occasional additional hemodialysis treatment to manage fluid overload might be enrolled as long as it was anticipated that no more than one such treatment would be required in any given week.

Note 2: Participants had received in-home hemodialysis might participated as long as they had switched to in-center hemodialysis at least two weeks prior to screening and plan to remain on in-center hemodialysis for the duration of the study.

• Hemodialysis participants meeting the Kidney Outcome Quality Initiative Guidelines of hemodialysis adequacy within 60 days of screening, two:

•Single-poolsKt/V measurements of at least 1.2.

• Pruritus for >= three months (documented pruritus with no etiology identified other than CKD by medical record, previous physician's letter/statement, or a written conversation of site investigators based on the medical history obtained from the participant).
• WI NRS score >= 5.0 at the screening and baseline visit. Screening WI NRS score would be determined by a single WI NRS assessment (score ranging from 0 to 10) for the 24-hour period immediately preceding the screening visit. Baseline WI NRS score would be determined based on the weekly average of daily WI NRS scores (score ranging from 0 to 10) during the seven days immediately preceding baseline (rounding was not permitted). A minimum of four daily scores out of the seven days immediately preceding baseline was required for this calculation.
• Women of childbearing potential (WOCBP) (i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agreed either to commit to true abstinence throughout the study and for 12 weeks after the last study drug injection, when this was in line with the preferred and usual lifestyle of the participant, or to use an adequate and approved method of contraception throughout the study and for 12 weeks after the last study injection.

Adequate and approved methods of contraception applicable for the participant and/or her partner were defined below:

• Progestogen-only oral hormonal contraception.
• Combination of male condom with cap, diaphragm, or sponge with spermicide (double-barrier methods).
• Combined (estrogen- and progestogen-containing) oral, intravaginal, or transdermal hormonal contraception.
• Injectable or implanted hormonal contraception.
• Intrauterine devices or intrauterine hormone releasing system.
• Bilateral tubal ligation or tube insert (such as the Essure system) at least three months before the study.
• Bilateral vasectomy of partner at least three months before the study.
• Women were considered to be of non-childbearing potential if they meet one of the following criteria:
• Absence of menstrual bleeding for one year prior to screening without any other medical reason, confirmed with follicle stimulating hormone (FSH) level in the postmenopausal range.
• Documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy at least three months before screening.

Note: Bilateral tubal ligation was not accepted as reason for non-childbearing potential.

• Participant was willing and able to comply with all time commitments and procedural requirements of the clinical study protocol.
• Understands and signs an informed consent form (ICF) before any investigational procedure(s) were performed.

Exclusion Criteria

• Body weight less than ( ) two days per week, night time awakenings two or more times per week, or some interference with normal activities) during the preceding three months.
• Asthma Control Test (ACT) 3 * upper limit of normal [ULN]) in combination with elevated bilirubin (>2 * ULN), during the screening period that might put the participant at significant risk according