ISRCTN74524864已完成2 期
A parallel-group (2-arm), randomized, double-blind, 12 week trial to evaluate the efficacy and safety of MC2 25 cream and MC2-25 vehicle in subjects with chronic kidney disease-associated pruritus (CKD aP)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 108
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Adult males or non-pregnant females of any race or ethnicity who are =18 years of age at the time of screening
- •2. Able to understand the trial and willing to comply with trial requirements
- •3. Has provided written informed consent
- •4. Chronic (>3 months) kidney disease (CKD) stages G3-G5 (i.e., estimated glomerular filtration rate [eGFR] by CKD-EPI creatinine 2021 equation <60 mL/min/1.73 m²)
- •5. Specifically for CKD subjects on haemodialysis (HD) or haemodiafiltration (HDF):
- •5.1. Subjects must be established on HD or HDF 3 times per week continuously for at least 3 months prior to the start of screening and must not have plans to change from HD to HDF or vice versa during the trial.
- •5.2. Subjects who require an occasional additional HD or HDF treatment to manage fluid overload may be enrolled as long as it is anticipated that no more than 4 such treatments will be required in any given month.
- •6. At least moderate CKD-aP defined as WI-NRS =4
- •7. Female subjects must be of either:
- •7.1. Non-childbearing potential, i.e., postmenopausal for a least 1 year or have a confirmed clinical history of sterility (e.g., hysterectomy or tubal ligation) or,
- •7.2. Childbearing potential with a negative urine pregnancy test at the Baseline visit or (in the case of anuria) a negative serum pregnancy test at the Baseline visit that is no more than 3 days old.
- •8. Female subjects of childbearing potential must agree to use a highly effective method of contraception (i.e., a method with a failure rate of less than 1% per year when used consistently and correctly) while receiving double-blind treatment. Highly effective contraception is defined as follows:
- •8.1. Combined (estrogen and progestogen-containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal
- •8.2. Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable
- •8.3. Intrauterine device (IUD)
- •8.4. Intrauterine hormone-releasing system (IUS)
- •8.5. Bilateral tubal occlusion
- •8.6. Vasectomised partner (provided that is the sole sexual partner of the subject and that the vasectomised partner has received medical assessment of the surgical success)
- •8.7. Sexual abstinence if in line with the preferred and usual lifestyle of the subject and defined as refraining from heterosexual intercourse during the entire period of the trial. Periodic methods of abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) are not accepted methods of contraception.
排除标准
- •1. In the opinion of the investigator, the subject is unlikely to comply with the clinical trial protocol.
- •2. Has a functioning kidney transplant or is scheduled to receive a kidney transplant during the trial
- •3. Subjects who receive peritoneal dialysis
- •4. In the opinion of the investigator has pruritus attributed to a cause other than CKD or its complications, including but not limited to dermatological disease (e.g., atopic dermatitis, psoriasis) or liver disease (cholestatic pruritus)
- •5. Has localized itch restricted to the palms of the hands
- •6. Only has pruritus during haemodialysis sessions
- •7. Has concurrent skin conditions that may limit or prevent application of MC2-25 cream or MC2-25 vehicle or that may interfere with evaluation of the effects of MC2-25 cream or MC2-25 vehicle on the skin at the Screening or Baseline visits
- •8. Subjects who will have skin biopsies performed must not have any known hypersensitivity to the local anaesthetic or diagnosed bleeding disorders. Note: subjects with suspected uremic platelet dysfunction, without other bleeding diatheses, can be enrolled if the investigator agrees.
- •9. Known history of allergic reaction to any ingredients in MC2-25 cream or MC2-25 vehicle
- •10. Has a concurrent or recent medical condition that, in the opinion of the investigator, could pose undue risk to the subject, impede completion of the trial procedures, or would compromise the validity of the trial measurements, including, but not limited to:
- •10.1. known or suspected abuser of alcohol, drugs, or narcotic substances
- •10.2. severe physical, mental or cognitive disorder other than CKD
- •10.3. malignancy
- •10.4. failure to comply with local COVID-19 regulations on vaccination or testing (due to risk of transmitting the disease to other trial participants
- •or trial staff).
- •11. Has a known current generalized infection
- •12. Is pregnant, breast feeding, or planning a pregnancy
- •13. Start of a new or change to existing systemic treatment for CKD-aP, including but not limited to antihistamines, corticosteroids, opioids, GABA analogues, or kappa opioid receptor agonists within 21 days prior to the Baseline visit
- •14. Use of emollients on CKD-aP areas within 10 days prior to the Baseline visit
- •15. Use of any topical treatment on CKD-aP areas, including but not limited to antihistamines, or corticosteroids within 21 days prior to the Baseline visit
- •16. Use of any light therapy for CKD-aP, including but not limited to UV-B within 35 days prior to the Baseline visit
- •17. Use of non-biologic systemic immunosuppressive treatment, including but not limited to corticosteroids, cyclosporin, and tacrolimus within 5 weeks prior to the Baseline visit
- •18. Use of biologic systemic treatment, including but not limited to etanercept, adalimumab, alefacept, infliximab, and ustekinumab within 3 months or 5 half-lives (whichever is longer) prior to the Baseline visit
- •19. Subjects who consent to having skin biopsies performed who are using anticoagulation treatment and are judged by the investigator to have an unacceptable risk of excessive bleeding in association with the skin biopsy
- •20. Subjects not currently on dialysis but who are likely to initiate routine dialysis during participation in the trial
- •21. Received another investigational drug within 30 days or 5 half-lives (whichever is longer) prior to screening or is planning to participate in another clinical trial while enrolled in this trial
- •22. Previously randomized in this trial
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