EUCTR2021-004766-35-HU进行中（未招募）1 期
A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Nemolizumab in Subjects with Chronic Kidney Disease with Associated Severe Pruritus
Galderma S.A.0 个研究点目标入组 252 人开始时间: 2022年4月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 252
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Subjects aged = 18 years at the screening visit.
- •2.Has end-stage kidney disease (ESKD) and has been on hemodialysis at least three times per week for at least three months prior to the start of screening.
- •Note 1: Subjects who require an occasional additional hemodialysis treatment to manage fluid overload may be enrolled as long as it is anticipated that no more than one such treatment will be required in any given week.
- •Note 2: Subjects having received in-home hemodialysis may participate as long as they have 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.
- •3.Hemodialysis subjects meeting the Kidney Outcome Quality Initiative Guidelines of hemodialysis adequacy within 45 days of screening, two:
- •Single-pool Kt/V measurements of at least 1.2.
- •4.Pruritus for = three months (documented pruritus with no etiology identified other than CKD by medical record, previous physician’s letter/statement, or written documentation by site investigators based on the medical history obtained from the subject).
- •5.WI NRS score = 7.0 at the screening and baseline visit. Screening WI NRS score will 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 will 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 is not permitted). A minimum of four daily scores out of the seven days immediately preceding baseline is required for this calculation.
- •6.Women of childbearing potential (WOCBP) (i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree either to commit to true abstinence throughout the study and for 12 weeks after the last study drug injection, when this is in line with the preferred and usual lifestyle of the subject, 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 subject and/or her partner are defined below:
- •Progestogen-only oral hormonal contraception.
- •Combination of male condom with cap, diaphragm, or sponge with spermicide (double-barrier methods).
- •Note: Double barrier methods” refers to simultaneous use of a physical barrier by each partner. Use of a single barrier method (e.g., condom) together with a spermicide is not acceptable.
- •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.
- •7.Women are 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 is not accepted as reason for non-childbearing potential.
- •8.Subject willing and able to comply with
排除标准
- •1.Body weight < 30 kg.
- •2.Pruritus caused by a concomitant condition unrelated to ESKD.
- •3.Localized itch of only the palms of the hands and/or soles of the feet.
- •4.Pruritus present only during hemodialysis session.
- •5.History of or anticipated non-compliance with hemodialysis.
- •6.New York Heart Association Class IV symptoms or myocardial infarction within three months prior to screening.
- •7.History of stroke or transient ischemic attack within six months prior to screening.
- •8.Subjects meeting one or more of the following criteria at screening or baseline:
- •a.Had an exacerbation of asthma requiring hospitalization in the preceding 12 months.
- •b.Reporting asthma that has not been well-controlled during the preceding three months.
- •c.Asthma Control Test (ACT) = 19 (only for subjects with a history of asthma).
- •9.Cutaneous infection within one week before the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within two weeks before the baseline visit.
- •10.Any confirmed or suspected coronavirus disease (COVID-19) infection within two weeks before the screening or baseline visit. Subjects may be rescreened after the infection has resolved. Resolution of COVID-19 infection can be confirmed by recovery assessment methods, as described in the protocol.
- •11.Positive serology results (hepatitis B surface antigen [HbsAg] or hepatitis B core antibody [HbcAb], hepatitis C [HCV] antibody with positive confirmatory test for hepatitis C virus [HCV] (e.g., HCV polymerase chain reaction [PRC]), or human immunodeficiency virus [HIV] antibody) at the screening visit.
- •Note: Subjects with a positive HbcAb and a negative HbsAg can be included in this clinical study if hepatitis B surface antibody is positive
- •. Subjects who are positive for HCV antibody and negative for HCV RNA may be enrolled.
- •In the event of rescreening, the serology tests results (e.g., HBV, HCV, HIV) from the previous screening can be used by the investigator to assess the eligibility of rescreened subjects if those tests were performed within six weeks prior to the baseline visit.
- •12.Known active or untreated latent tuberculosis (TB) infection or history of either untreated or inadequately treated active or latent TB according to the local applicable guidelines.
- •Note: Subjects who have a documented history of completion of an appropriate TB treatment regimen for latent or active TB with no history of re-exposure to TB since their treatment was completed are eligible to participate in the study.
- •13.Known or suspected immunosuppression beyond that expected due to end-stage kidney disease and its comorbidities or unusually frequent, recurrent, severe, or prolonged infections as per investigator judgment.
- •14.History of lymphoproliferative disease or history of malignancy of any organ system within the last five years, except for (1) basal cell carcinoma, squamous cell carcinoma in situ (Bowen’s disease), or carcinomas in situ of the cervix that have been treated and have no evidence of recurrence in the last 12 weeks before the baseline visit, or (2) actinic keratoses that have been treated.
- •15.Pregnant women, breastfeeding women, or women planning a pregnancy during the clinical study.
- •16.In the opinion of the investigator the subject has any medical or psychological condition that could pose undue risk to the subject, prevent study completion, or adversely affect the validity or interpretability of the study measurements
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