A Phase 2 Study to Evaluate the Safety and Efficacy of Escalated and Fixed Doses of VS-505(AP301) in Comparison With Sevelamer Carbonate to Treat Hyperphosphatemia in Chronic Kidney Disease Patients Receiving Hemodialysis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 158
- 试验地点
- 23
- 主要终点
- Serum phosphorus change from baseline to end of treatment
研究概览
简要总结
A multi-center, open-label, parallel-design, active-controlled phase 2 study to evaluate the tolerability, safety and efficacy of various dosages of VS-505 compared with Sevelamer Carbonate when given orally with meal for 6 weeks to treat hyperphosphatemia in chronic kidney disease subjects receiving maintenance hemodialysis.
详细描述
The main body of this study has 5 intervention arms, 4 VS-505 treatment arms of various dosage plus 1 active control arm of Sevelamer Carbonate, each consists 25 subjects. Prior to this main part, a dose escalating cohort of 25 subjects is added to evaluate the tolerability of VS-505 in Chinese patient population.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with end stage renal disease who are receiving a stable hemodialysis regimen (3 times per week) with sufficient dialysis adequacy;
- •Serum phosphorus level range from >1.94 mmol/L (6.0 mg/dL) to ≤3.23 mmol/L (10.0 mg/dL) at the end of washout phase.
排除标准
- •Kidney transplant patient or scheduled kidney transplant, or change to peritoneal dialysis, home hemodialysis or plan to relocate to another dialysis center during the study period；
- •Serum phosphorus level is <1.29 mmol/L（4.0 mg/dL) or >2.42 mmol/L（7.5 mg/dL) at screening, or documented to be >3.23 mmol/L（10 mg/dL) within the latest three month prior to screening (screening included);
- •Serum calcium level is <8 mg/dL or >11 mg/dL at the screening;
- •Serum immunoreactive parathyroid hormone (iPTH)>1000 pg/mL at the screening;
- •History of hemochromatosis or serum ferritin value ≥1000 μg/L at screening；
- •Current clinically significant gastrointestinal (GI) disorder, or history of intestine obstruction, gastrectomy or duodenectomy, or GI tract surgery within 12 weeks prior to screening;
- •Poorly controlled hypertension, cardiovascular disorders, and history of cerebrovascular disease or cardiovascular disease event within 24 weeks (6 months) prior to screening.
研究组 & 干预措施
VS-505 500mg
VS-505 500mg (two 250 mg capsules) oral administration three times a day with meal, daily total dosage 1500mg.
干预措施: VS-505 (Drug)
VS-505 750mg
VS-505 750mg (one 750 mg capsule) oral administration three times a day with meal, daily total dosage 2250mg.
干预措施: VS-505 (Drug)
VS-505 1500mg
VS-505 1500mg (two 750 mg capsules) oral administration three times a day with meal, daily total dosage 4500mg.
干预措施: VS-505 (Drug)
VS-505 2250mg
VS-505 2250mg (three 750 mg capsules) oral administration three times a day with meal, daily total dosage 6750mg.
干预措施: VS-505 (Drug)
Sevelamer Carbonate 1600mg
Sevelamer Carbonate 1600mg (two 800mg pills) oral administration three times a day with meal, daily total dosage 4800mg.
干预措施: Sevelamer Carbonate (Drug)
结局指标
主要结局
Serum phosphorus change from baseline to end of treatment
时间窗: 6 weeks
次要结局
- Time to serum phosphorus response，defined as serum phosphorus level decrease by 0.32 mmol/L（1 mg/dL）and serum phosphorus level below 1.78 mmol/L（5.5 mg/dL）(6 weeks)
- The achievement rate of subjects with serum phosphorus in the target range 1.13-1.78 mmol/L（3.5-5.5 mg/dL）by the end of treatment(6 weeks)
- Serum calcium change from baseline to end of treatment(6 weeks)
- Serum Ca×P change from baseline to end of treatment(6 weeks)
- Serum iPTH change from baseline to end of treatment(6 weeks)