EUCTR2018-001930-17-CZ进行中（未招募）1 期
A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF INTRAVENOUS CR845 IN HEMODIALYSIS PATIENTS WITH MODERATE-TO-SEVERE PRURITUS, WITH A 52-WEEK OPEN-LABEL EXTENSION - CR845-CLIN3103
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 350
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
入选标准
- •Inclusion Criteria:
- •To be eligible for inclusion into the Double-blind Phase of the study, a patient must meet the following 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 understand the study procedures, and able and willing
- •to comply with the study requirements, including providing written responses to questionnaires;
- •3.Male or female between 18 and 85 years of age inclusive; Note: Subjects in Korea, must be male or female between 19 and 85 years of age, inclusive.
- •4.Has end-stage renal disease (ESRD) and has been on hemodialysis 3 times per week for at least 3 months prior to the start of screening;
- •Note 1: Patients who require an occasional additional dialysis treatment to manage fluid overload or electrolyte excesses may be enrolled as long as it is anticipated that no more than 1 such treatment will be required in any given week and no More than 4 occasions during the 12-week double-blind period. Patients routinely on 4 dialyses a week will not be eligible.
- •Note 2: Patients receiving in-home hemodialysis may participate as long as they have switched to in-center hemodialysis at least 2 weeks prior to screening and plan to remain on in-center hemodialysis for the duration of the study.
- •Note 3: Patients receiving alternate dialysis modalities such as nocturnal dialysis will not be eligible.
- •5.If female, is not pregnant or nursing during any period of the study;
- •6.If female:
- •a.Is surgically sterile; or
- •b.Has been amenorrhoeic for at least 1 year and is over the age of 55 years; or
- •c.Has a negative serum pregnancy test at screening and agrees to use acceptable contraceptive measures
- •(eg, hormonal contraceptives, barrier with spermicide, intrauterine device, vasectomized partner, or abstinence) from the time of informed consent until 7 days after the last dose of study drug;
- •7.If male, agrees not to donate sperm after the first dose of study drug until 7 days after the last dose of study drug, and agrees to use a condom with spermicide or abstain from heterosexual intercourse during the study until 7 days after the last dose of study drug. (Note: No restrictions are required for a
- •vasectomized male provided his vasectomy was performed
- •=4 months prior to screening);
- •8.Has a prescription dry body weight between 40.0 and 135.0 kg, inclusive;
- •9.Has 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;
- •10.Prior to randomization:
- •a.Has completed at least four out of eight Worst Itching
- •Intensity Numerical Rating Scale (NRS) worksheets fromhe start of the 7-day Run-in Period up to and including the
- •pre-randomization assessment on Day 1;
- •b.Has a mean baseline Worst Itching Intensity NRS score
- •=5, defined as the average of all non-missing scores reported from the start of the 7-d
排除标准
- •Exclusion Criteria:
- •A patient will be excluded from the Double-blind Phase of the study if
- •any of the following criteria are met:
- •1. Known noncompliance with dialysis treatment that in the
- •opinion of the Investigator would impede completion or
- •validity of the study;
- •2. Scheduled to receive a kidney transplant during the study;
- •3. Known history of allergic reaction to opiates, such as hives
- •(Note: side effects related to the use of opioids, such as
- •constipation or nausea, would not exclude patients from the
- •4. Has a concomitant disease or a history of any medical
- •condition that, in the opinion of the Investigator, could pose
- •undue risk to the patient, impede completion of the study
- •procedures, or would compromise the validity of the study
- •measurements, including, but not limited to:
- •a. Known or suspected history of alcohol, narcotic, or other
- •drug abuse, or substance dependence within 12 months
- •prior to screening;
- •b. Significant systolic or diastolic heart failure (eg, New
- •York Heart Association Class IV congestive heart failure
- •[Appendix 1, Section 14.1]);
- •c. Severe mental illness or cognitive impairment (eg,
- •d. Any other relevant acute or chronic medical or
- •neuropsychiatric condition within 3 months prior to
- •screening (eg, diagnosis of encephalopathy, coma,
- •5. New or change of treatment received for itch including
- •antihistamines and corticosteroids (oral, IV, or topical) within
- •14 days prior to screening; 6. New or change of prescription for opioids, gabapentin, or
- •pregabalin within 14 days prior to screening;
- •7. Received another 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;
- •8. In the opinion of the Investigator, has pruritus attributed to a
- •cause other than ESRD or its complications (eg, patients with
- •concomitant pruritic dermatological disease or cholestatic liver
- •disease) (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
- •11. Is receiving ongoing ultraviolet B treatment and anticipates
- •receiving such treatment during the study;
- •12. Participated in a previous clinical study with CR845.
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