EUCTR2022-000149-34-ES进行中（未招募）1 期
A Multicenter, Randomized, Double-blind, Placebo-controlled 12-Week Study to Evaluate the Safety and Efficacy of Oral Difelikefalin in Advanced Chronic Kidney Disease Subjects with Moderate-to-Severe Pruritus and not on Dialysis with an up to 52-Week Long-term Extension
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
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. Willing and able to provide written informed consent prior to participating in this study.
- •2. Able to communicate clearly with the study investigator and staff and complete the required study procedures and questionnaires.
- •3. Subjects aged 18 to 85 years, inclusive, at the time of consent.
- •4. Not currently on dialysis with advanced CKD (ie, estimated glomerular filtration rate (eGFR) =29 mL/min/1.73 m2 calculated using chronic kidney disease-Epidemiology Collaboration (CKD-EPI) creatinine equation [2021]) based on either a screening laboratory serum creatinine value from this study or at least 2 documented serum creatinine values collected at least 90 days apart within 1 year prior to screening.
- •5. Subject self-reports experiencing daily or near-daily pruritus for at least 6 months prior to screening.
- •6. Inadequate response to current or prior topical treatments (including emollients) for pruritus prior to screening.
- •7. Female subject is not pregnant or nursing during any period of the study.
- •8. If female of childbearing potential, must have a negative serum ß-human chorionic gonadotropin pregnancy test result at screening and a negative urine pregnancy test result within 7 days prior to randomization.
- •9. For females, subject must be of nonchildbearing potential defined as:
- •a. Postmenopausal: For women aged 55 years or younger, postmenopausal state should be confirmed by a high follicle-stimulating hormone (FSH) level (> 40 IU/L or > 40 mIU/mL).
- •No FSH confirmation is required in women older than 55 years; or
- •b. Surgically sterile (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy).
- •Or, of childbearing potential involved in sexual intercourse that could lead to pregnancy and:
- •Agrees to use an adequately effective method of contraception: (eg, hormonal contraceptives from at least 30 days prior to Day 1 until 7 days after the last dose of study drug from the time of informed consent until 7 days after the last dose of study drug.
- •Note: The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the subject. Periodic abstinence (calendar, symptothermal, post ovulation methods) is not acceptable.
- •10. For male subjects involved in any sexual intercourse that could lead to pregnancy, subject must agree to use one of the accepted effective contraceptive methods, from Day 1 (first day of treatment) until at least 7 days after the last study product administration. If the female partner of a male subject uses any of the accepted hormonal contraceptive methods and is the only form of contraception used, this contraceptive method should be used by the female partner from at least 4 weeks before Day 1 until at least 7 days after the last dose of study drug. Male subjects must agree not to donate sperm during the study and for 7 days after receiving the study drug. No restrictions are required for a vasectomized male provided his vasectomy was performed = 4 months prior to screening.
- •11. Prior to randomization on Day 1 of Treatment Period 1:
- •a. Has recorded at least 4 WI-NRS scores during the 7-day Run-in Period; and
- •b. Has a mean baseline WI-NRS score = 5, defined as the average of all non-missing scores reported during the 7-day Run-in Period.
- •To be eligible for inclusion into the Long-term Extension Phase of the study, each subject will have to fulfill the additional following criteria at the time of entry into the Long-term Extension
排除标准
- •1. Scheduled to receive renal replacement therapy (dialysis or kidney transplant) during the study.
- •2. Has a concomitant disease, significant medical condition or physical/laboratory/ECG/vital signs abnormality that, in the opinion of the investigator, puts the subject at undue risk or interferes with interpretation of study results, impedes completion of the study procedures, or compromises the validity of the study measurements.
- •3. Subject has a known history of clinically significant drug or alcohol abuse in the last year prior to Day 1.
- •4. Subject had a major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study.
- •5. Subjects with hypernatremia or a history of hypernatremia.
- •6. Subjects unable to sense or respond to thirst appropriately.
- •7. New or change of treatment received for itch, including antihistamines and corticosteroids (oral, intravenous, or topical), within 14 days prior to screening.
- •8. New or change of prescription for gabapentinoids, selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, anticonvulsants/mood stabilizers, tricyclic antidepressants, opioids or benzodiazepines within 14 days prior to screening.
- •9. Serum alanine aminotransferase or aspartate aminotransferase greater than 2.5 times the reference upper limit of normal (ULN) and/or total bilirubin greater than 1.5 times the upper limit of normal (ULN) at screening.
- •10. Received an investigational drug within 30 days prior to the start of screening or is planning to participate in another clinical study while enrolled in this study.
- •11. Has pruritus attributed to a cause other than chronic kidney disease (eg, pruritus associated with dermatological, hepatobiliary, neuropathic, and/or hematologic disorders).
- •12. Has localized itch restricted to the palms of the hands.
- •13. Receiving an opioid antagonist (eg, naloxone, naltrexone) or opioid-mixed agonist-antagonist (eg, buprenorphine, nalbuphine) within 14 days prior to the start of screening and/or anticipates receiving such medications during the study.
- •14. Received ultraviolet B treatment within 30 days prior to screening and/or anticipates receiving such treatment during the study.
- •15. Has a known or suspected allergy to difelikefalin or any component of the investigational product.
- •16. Subject has a history of cancer or lymphoproliferative disease within 5 years prior to Day 1. Subjects with successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix are not to be excluded.
- •17. Subject has a current condition resulting in chronic dehydration (eg, ongoing vomiting, chronic diarrhea) or a condition that, in the opinion of the investigator, could predispose to dehydration.
- •A subject will be excluded from the Long-term Extension Phase of the study if any of the additional following criteria are met at the time of entry into the Long-term Extension Phase.
- •18. Experienced AEs during the course of Treatment Period 1 that may preclude continued exposure to the study drug.
- •19. Was noncompliant with protocol procedures during the Efficacy Assessment Phase of this study which is indicative of an inability to follow protocol procedures.
- •20. Has developed a concomitant disease or any medical condition that, in the opinion of the investigator, could pose undue risk to the subject, impedes completion of the study procedures, or would compromise the validity of the study measurements.
研究者
相似试验
已完成
3 期
Trial to Assess Parkinson's Disease (PD) Symptom Control to Four Doses of Rotigotine in a Transdermal PatchCTRI/2009/091/001069SCHWARZ BIOSCIENCES, Inc.8010 Arco Corporate Drive, Suite 100 Raleigh, NC 27617, USA500
进行中（未招募）
不适用
An Efficacy and Safety Study of intravenous Golimumab in patients with Active Rheumatoid Arthritis (RA) despite treatment with methotrexate, non steroidal pain medications and/or corticosteroidsEUCTR2008-006064-11-LTJanssen Biologics B.V.564
进行中（未招募）
不适用
A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha TherapyRheumatoid ArthritisEUCTR2010-022243-38-PTJanssen-Cilag International N.V.840
未知
2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Trial to Evaluate the Efficacy and Safety of Dapagliflozin as Monotherapy in Japanese Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic ControlType 2 Diabetes MellitusJPRN-jRCT2080220880AstraZeneca
进行中（未招募）
1 期
A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis, dependent on Corticosteroids. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 13 (Week 36). During maintenance doses the investigator will try to slowly reduce the patient's corticosteroid dose.Myasthenia GravisEUCTR2013-005099-17-DEGrifols Therapeutics Inc.60