A phase 2, randomized, double-blind, placebo-controlled, dose-finding 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
- 384
研究概览
简要总结
The reduction amount was shown to be significantly large in the KHK7791 groups in comparison with the placebo group, even at 5 mg, the lowest dose of KHK7791 in Japanese patients with hyperphosphatemia undergoing hemodialysis. Also, KHK7791 reduced serum phosphorus levels with increasing dose up to 30 mg, the highest dose in this study.The percentage of subjects who achieved the target level (<= 6.0 mg/dL) was higher in the KHK7791 groups than in the placebo group. The most common AE and drug-AE was mild diarrhoea in all groups. The incidence of TEAEs and drug-related TEAEs was lower in the KHK7791 30 mg down-titration group than in the 30 mg group, which suggested that dose reduction can reduce the risk of TEAEs and drug-related TEAEs. According to the above, the starting dose of KHK7791 will be 5 mg and the dose will be adjusted within the range of 5 to 30 mg in the next phase of clinical studies.
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 4 weeks before screening examination.
- •4) Serum phosphorus levels should be in the range of >=3.5 and =<6.0 mg/dL at screening examination. etc.
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.