A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Comparative Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Changes in serum phosphorous levels from baseline values at 8 weeks after the start of administration.
研究概览
简要总结
To evaluate the efficacy of KHK7791 by comparing changes in serum phosphorus levels from baseline values between hemodialysis patients with hyperphosphatemia receiving repeated administration of KHK7791 for 8 weeks and those receiving placebo.
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)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has voluntarily provided written informed consent to participate in the study.
- •Aged ≥ 20 years (expressed in completed years) at the time of providing informed consent.
- •Stable chronic renal failure patients who have undergone hemodialysis 3 times per week for at least 12 weeks until screening examination.
- •Dialysis conditions (dialysate, dialyzer, frequency of dialysis per week, dialysis duration, blood flow rate, and dialysate and substitution fluid flow rates), excluding dry weight, should have been unchanged during the last 2 weeks before screening examination.
- •The prescribed drug and dosage regimen should have been unchanged during the last 4 weeks before screening examination.
- •Serum phosphorus levels should be in the range of ≥ 3.5 and ≤ 6.0 mg/dL at screening examination.
- •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.
- •Kt/V urea ≥ 1.2 at the most recent test in routine medical practice before screening examination.
排除标准
- •Peritoneal dialysis was performed within 12 weeks before screening examination.
- •iPTH >600 pg/mL (should be based on the most recent value from the patients' medical records, etc. before pre-enrollment)
- •Having concurrent or a history of inflammatory bowel disease (IBD) or diarrhea-predominant irritable bowel syndrome
- •History of gastrectomy or enterectomy or having undergone gastrointestinal tract surgery within 3 months before screening examination.
- •Subjects who used anti RANKL preparations within 6 weeks before screening examination.
- •Subjects who used anti-sclerostin antibody preparations within 12 weeks before screening examination.
- •Having concurrent severe heart disease or hepatic impairment.
- •Developed cerebrovascular disease or cardiovascular disease requiring hospitalization within 6 months before screening examination.
- •Uncontrollable hypertension or diabetes.
- •Scheduled for living donor kidney transplant, change in the mode of dialysis, home hemodialysis, or change in the dialysis center during the study period.
- •Any diagnosis of and treatment of malignancy within 5 years before screening examination.
研究组 & 干预措施
KHK7791
During the dosing period, subjects administer the study drug (KHK7791 or placebo) twice daily just before meals in a double blind. The starting dose of the study drug is 5 mg at a time, and the dose is adjusted in the range of 5, 10, 20, and 30 mg at a time based on the dose adjustment criteria described in the study protocol. Dosage adjustment is performed step by step.
干预措施: KHK7791 (Drug)
Placebo
During the dosing period, subjects administer the study drug (KHK7791 or placebo) twice daily just before meals in a double blind. The starting dose of the study drug is 5 mg at a time, and the dose is adjusted in the range of 5, 10, 20, and 30 mg at a time based on the dose adjustment criteria described in the study protocol. Dosage adjustment is performed step by step.
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in serum phosphorous levels from baseline values at 8 weeks after the start of administration.
时间窗: Week 8
次要结局
- Achievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 5.5).(Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.)
- Time when the target serum phosphorus level (serum phosphorus level: ≤ 5.5) was achieved.(Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.)
- Concentrations of such as Ca × P product levels at each time point.(Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.)
- Changes of such as Ca × P product levels from baseline values at each time point.(Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.)
- Changes in serum phosphorous levels from baseline values at each time point.(Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.)
- Achievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 6.0).(Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.)
- Time when the target serum phosphorus level (serum phosphorus level: ≤ 6.0) was achieved.(Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.)