A phase 2, randomized, double-blind, placebo-controlled, phosphate binder-combination study of KHK7791 in hyperphosphatemia patients on hemodialysis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 133
研究概览
简要总结
The results of the primary endpoint in this study demonstrated that 6-week repeated administration of KHK7791 in combination with phosphate binders significantly reduced serum phosphorus levels compared with placebo in combination with phosphate binders in hyperphosphatemia patients on hemodialysis whose serum phosphorus levels were poorly controlled by existing phosphate binders (p< 0.001, t-test). No changes in serum phosphorus levels were observed in the placebo group after the start of treatment. On the other hand, in the KHK7791 group, serum phosphorus levels after the start of treatment decreased by Week 1 and remained around the decreased level thereafter. The percentage of subjects who achieved the target serum phosphorus level (<= 6.0 mg/dL or <= 5.5 mg/dL) was higher in the KHK7791 group than in the placebo group. Of the 23 subjects who received KHK7791, 16 (69.6%) completed the 6-week treatment, during which their gastrointestinal symptoms were controlled by measures such as dose reduction. The gastrointestinal symptoms leading to dose reduction were resolved after the dose was reduced. From these findings, although diarrhea occurred frequently, the dosing regimen of KHK7791 used in this study was considered tolerable.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 79age old（—）
- 性别
- All
入选标准
- •1) Patients with stable chronic renal failure who have undergone hemodialysis three times per week for at least 12 weeks until screening examination.
- •2) 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.
- •3) Taking phosphate binders three times per day. The prescribed drug and dosage regimen should have been unchanged during the last 2 weeks before screening examination.
- •4) Serum phosphorus levels should be in the range of >=6.1 and <10.0 mg/dL at screening examination.
排除标准
- •1) iPTH >600 pg/mL
- •2) Having concurrent or a history of inflammatory bowel disease (IBD) or diarrhea-predominant irritable bowel syndrome
- •3) History of gastrectomy or enterectomy (excluding endoscopic resection and cecectomy) or having undergone gastrointestinal tract surgery within 3 months before screening examination. etc.