JPRN-jRCT2051200145进行中（未招募）3 期
A Phase 3, Open-label, Single-arm Clinical Study of KHK7791 in Hyperphosphatemia Patients on Peritoneal Dialysis
Kinoshita Jun0 个研究点目标入组 40 人开始时间: 2021年3月4日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
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
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Has voluntarily provided written informed consent to participate in the study.
- •2) Aged >= 20 years (expressed in completed years) at the time of providing informed consent.
- •3) Stable chronic renal failure patients who have undergone peritoneal dialysis 3 times per week for at least 12 weeks until screening examination.
- •4) Dialysis conditions should have been unchanged during the last 2 weeks before screening examination.
- •5) The prescribed drug and dosage regimen should have been unchanged during the last 2 weeks before screening examination.
- •6) Serum phosphorus levels should be in the range of >= 3.5 and =< 7.0 mg/dL at screening examination.
- •7) If on any vitamin D, calcimimetics regimen, bisphosphonate,calcitonin preparations, selective estrogen receptor modulators or teriparatide preparations then the prescribed drug and dosage regimen should have been unchanged for the last 4 weeks before screening examination.
排除标准
- •1) Subjects who received concomitant hemodialysis or hemodialysis filtration within 12 weeks before screening examination.
- •2) Having concurrent or a history of inflammatory bowel disease (IBD) or diarrhea-predominant irritable bowel syndrome
- •3) History of gastrectomy or enterectomy or having undergone gastrointestinal tract surgery within 3 months before screening examination.
- •4) Subjects in whom peritonitis, catheter-related infections, catheter dysfunction, etc. are confirmed within 4 weeks before screening examination., and the continuation of peritoneal dialysis is considered to be interfering with the implementation of peritoneal dialysis.
- •5) Subjects who used anti RANKL preparations within 6 weeks before screening examination.
- •6) Subjects who used anti-sclerostin antibody preparations within 12 weeks before screening examination.
- •7) Having concurrent severe heart disease or hepatic impairment.
- •8) Developed cerebrovascular disease or cardiovascular disease requiring hospitalization within 6 months before screening examination.
- •9) Subjects who have undergone parathyroid intervention within 24 weeks before screening examination, or subjects who are scheduled to undergo parathyroid intervention between the implementation of the pretest and the completion of the study.
- •10) Uncontrollable hypertension or diabetes.
- •11) Scheduled for living donor kidney transplant, change in the mode of dialysis, home hemodialysis, or change in the dialysis center during the study period.
- •12) Any diagnosis of and treatment of malignancy within 5 years before screening examination.
- •13) Tested positive for HIV or HTLV-1.
- •14) Expected to develop serious drug allergies, such as anaphylactic shock, or any history of alcohol dependence, illicit drug use, severe mental illness, or drug abuse or addiction within 12 months before screening examination.
- •15) Not expected to live for >= 12 months.
- •16) Received other study drugs within 4 weeks before screening examination.
- •17) Has received KHK7791.
研究者
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