A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Oral CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 269
- 试验地点
- 3
- 主要终点
- Change From Baseline in Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score During Week 12
研究概览
简要总结
This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of 3 dose levels of oral CR845 compared to placebo in reducing the intensity of itch in chronic kidney disease (CKD) patients with moderate-to-severe pruritus. This study will consist of a Screening Period, a 7-day Run-in Period, a 12 week Treatment Period, and a Follow-up Visit (approximately 7 days after the last dose of study drug).
详细描述
This study will consist of a Screening Period, a 7-day Run-in Period, a 12 week Treatment Period, and a Follow-up Visit (approximately 7 to 10 days after the last dose of study drug). Informed consent will be obtained prior to performing any study-specific procedures. Screening will occur within 7 to 28 days prior to randomization to assess eligibility.
If patients continue to meet all inclusion and no exclusion criteria at the end of the 7-day Run-in Period, they will be randomized in a 1:1:1:1 ratio to receive orally once daily either placebo or CR845 tablets at doses of 0.25, 0.5 or 1 mg. Randomization will be stratified according to the patient's renal disease status: moderate CKD; severe CKD non-dialysis; severe CKD on dialysis (ie, 3 categories). A final safety Follow-up Visit will be conducted 7 to 10 days after the last dose of study drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
CR845 will be provided as enteric-coated tablets. All tablets are white in color with no markings and are identical in appearance, regardless of dose.
CR845 tablets will be provided at doses of 0.25, 0.5, and 1 mg.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible for inclusion into the study, a patient must meet the following criteria:
- •CKD patients with stage III, IV, or V (ie, moderate renal impairment with estimated glomerular filtration rate (GFR) ≥30 and <60 mL/min/1.73 m2 or severe renal impairment with estimated GFR <30 mL/min/1.73 m2).
- •For severe CKD patients on hemodialysis, they must be receiving hemodialysis 3 times per week for at least 3 months prior to the start of screening;
- •Prior to randomization:
- •Has completed at least 4 Worst Itching Intensity NRS worksheets from the start of the 7-day Run-in Period;
- •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-day Run-in Period.
排除标准
- •A patient will be excluded from the study if any of the following criteria are met:
- •Patients not currently on dialysis who are likely to initiate routine dialysis during study participation;
- •Scheduled to receive a kidney transplant during the study;
- •New or change of treatment received for itch including antihistamines and corticosteroids (oral, intravenous [IV], or topical) within 14 days prior to screening;
- •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;
- •Received ultraviolet B treatment within 30 days prior to the start of screening or anticipates receiving such treatment during the study;
- •Participated in a previous clinical study with CR845.
研究组 & 干预措施
CR845 0.25 mg Oral Tablet
Oral CR845 0.25 mg to be taken orally once daily for 12 weeks
干预措施: CR845 0.25 mg Oral Tablet (Drug)
CR845 0.5 mg Oral Tablet
Oral CR845 0.5 mg to be taken orally once daily for 12 weeks
干预措施: CR845 0.5 mg Oral Tablet (Drug)
CR845 1 mg Oral Tablet
Oral CR845 1 mg to be taken orally once daily for 12 weeks
干预措施: CR845 1 mg Oral Tablet (Drug)
Placebo Oral Tablet
Oral Placebo to be taken orally once daily
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Change From Baseline in Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score During Week 12
时间窗: Baseline, Week 12
Intensity of itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable". Higher scores meant worse itch intensity.
次要结局
- Change From Baseline in Total Skindex-10 Scale Score at the End of Week 12(Baseline, Week 12)
- Change From Baseline in 5-D Itch Scale Score at the End of Week 12(Baseline, Week 12)
- Reduction of Itch Intensity as Assessed by the Proportion of Patients Achieving an Improvement From Baseline ≥3 Points With Respect to the Weekly Mean of the Daily 24-hour Worst Itching Intensity NRS Score at Week 12(Week 12)