NCT03864458已完成2 期
A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-finding Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- To investigate the clinically recommended dose by comparing changes in serum phosphorus levels from baseline values at Week 6.
研究概览
简要总结
To evaluate the effect and safety of KHK7791 to treat Hyperphosphatemia in ptatients on HD.
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, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with stable chronic renal failure who have undergone hemodialysis three 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.
- •Taking phosphate binders three times per day. 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 or calcimimetics regimen, then the prescribed drug and dosage regimen should have been unchanged for the last 4 weeks before screening examination.
排除标准
- •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 (excluding endoscopic resection and cecectomy) or having undergone gastrointestinal tract surgery within 3 months before screening examination.
- •Having concurrent severe heart disease [including congestive heart failure, defined as New York Heart Association (NYHA) cardiac functional classification of class III or IV, and cardiovascular disease requiring hospitalization, such as myocardial infarction] or hepatic impairment (including AST/ALT ≥100 U/L at screening examination, or cirrhosis).
- •Developed cerebrovascular disease (such as cerebral infarction and hemorrhage) or cardiovascular disease (such as myocardial infarction and unstable angina) 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 (relocate to another hospital/clinic) during the study period.
- •Any diagnosis of and treatment of malignancy within 5 years before screening examination (excluding basal cell carcinoma or surgically resected intraepithelial carcinoma of uterine cervix).
研究组 & 干预措施
KHK7791 A
Experimental
Patients take KHK7791 low dose BID.
干预措施: KHK7791 (Drug)
KHK7791 B
Experimental
Patients take KHK7791 middle dose BID.
干预措施: KHK7791 (Drug)
KHK7791 C
Experimental
Patients take KHK7791 high dose BID.
干预措施: KHK7791 (Drug)
KHK7791 D
Experimental
Patients start at KHK7791 high dose and can down titrate weekly ,based on a GI tolerability question.
干预措施: KHK7791 (Drug)
Placebo
Placebo Comparator
Patients take Placebo BID.
干预措施: Placebo (Drug)
结局指标
主要结局
To investigate the clinically recommended dose by comparing changes in serum phosphorus levels from baseline values at Week 6.
时间窗: Week 6
次要结局
- Changes in serum Ca × P levels from baseline.(Week 6)
- Changes in corrected serum calcium levels from baseline.(Week 6)
研究者
研究点 (1)
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