LBCTR2022125201已完成2 期
An Open-label, Single Arm Study to Evaluate the Pharmacokinetics of a Single Dose of Intravenous Difelikefalin in Adolescents Aged 12 to 17 Years on Haemodialysis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 12 至 17（—）
- 性别
- All
入选标准
- •1. End-stage renal disease (ESRD) subjects who have been on HD for at least 3 months and are currently on HD at least 3 times per week. Subjects with or without associated pruritus may enroll.
- •2. Males or females 12 to 17 years of age, at the time of consent.
- •3. Has a prescription dry body weight =20 kg and =100 kg.
排除标准
- •1. Known to be non-compliant with HD treatments and deemed unlikely to complete the study by the Investigator (i.e., has a history of missed HD
- •sessions due to non-adherence in the past 2 months).
- •2. Planned or anticipated to receive a kidney transplant during the study. Note: Being on a kidney transplant list is not an exclusion criterion.
- •3. Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) greater than 2.5 × the reference upper limit of normal (ULN), or bilirubin greater than 4 × the ULN at screening.
- •4. Subject has known hypersensitivity to the study drug or any components of the difelikefalin formulation.
- •5. 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 the subjects from the study.
- •6. Previous participation in this study.
- •7. Known or suspected history of alcohol, narcotic, or other drug abuse or substance dependence within 12 months prior to screening.
- •8. Acute or unstable medical condition(s) which in the opinion of the Investigator would pose undue risk to the subject or would impede complete
- •collection of evaluable data.
研究者
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