To Evaluate the Tolerance, pd, and pk of Lanthanum Polystyrene-sulfonate Powder in a Phase Ib/ IIa Clinical Trial in Patients With ESRD-HD Hyperphosphatemia With Multi-center, Multi-dose, Give the Drug Multiple Time
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Blood phosphate concentrations
研究概览
简要总结
The aim of the study is:
To evaluate the tolerance of lanthanum polystyrene sulfonate powder in patients with end-stage renal disease (ESRD-HD) hyperphosphatemia with multiple doses and multiple doses； To evaluate the pharmacodynamics of lanthanum polystyrene sulfonate powder in hyperphosphatemia patients with end-stage renal disease on hemodialysis (ESRD-HD); To evaluate the pharmacokinetics of lanthanum polystyrene sulfonate powder in patients with end-stage renal disease (ESRD-HD) hyperphosphatemia after multi-dose and multiple administration.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
group 2:dose 3g
There were 12 subjects in the group, 8 of whom took lanthanum polystyrene sulfonate powder, 2 took placebo, and 2 took positive control drug （lanthanum carbonate）
干预措施: Lanthanum Polystyrene Sulphonate Powder (Drug)
group 1:dose 1.5g
There were 12 subjects in the group, 8 of whom took lanthanum polystyrene sulfonate powder, 2 took placebo, and 2 took positive control drug （lanthanum carbonate）
干预措施: Lanthanum Polystyrene Sulphonate Powder (Drug)
group 1:dose 1.5g
There were 12 subjects in the group, 8 of whom took lanthanum polystyrene sulfonate powder, 2 took placebo, and 2 took positive control drug （lanthanum carbonate）
干预措施: Lanthanum Carbonate 500 MG (Drug)
group 1:dose 1.5g
There were 12 subjects in the group, 8 of whom took lanthanum polystyrene sulfonate powder, 2 took placebo, and 2 took positive control drug （lanthanum carbonate）
干预措施: Placebo (Drug)
group 2:dose 3g
There were 12 subjects in the group, 8 of whom took lanthanum polystyrene sulfonate powder, 2 took placebo, and 2 took positive control drug （lanthanum carbonate）
干预措施: Lanthanum Carbonate 500 MG (Drug)
group 2:dose 3g
There were 12 subjects in the group, 8 of whom took lanthanum polystyrene sulfonate powder, 2 took placebo, and 2 took positive control drug （lanthanum carbonate）
干预措施: Placebo (Drug)
group 3:dose 4.5g
There were 12 subjects in the group, 8 of whom took lanthanum polystyrene sulfonate powder, 2 took placebo, and 2 took positive control drug （lanthanum carbonate）
干预措施: Lanthanum Polystyrene Sulphonate Powder (Drug)
group 3:dose 4.5g
There were 12 subjects in the group, 8 of whom took lanthanum polystyrene sulfonate powder, 2 took placebo, and 2 took positive control drug （lanthanum carbonate）
干预措施: Lanthanum Carbonate 500 MG (Drug)
group 3:dose 4.5g
There were 12 subjects in the group, 8 of whom took lanthanum polystyrene sulfonate powder, 2 took placebo, and 2 took positive control drug （lanthanum carbonate）
干预措施: Placebo (Drug)
group 4:dose 6g
There were 12 subjects in the group, 8 of whom took lanthanum polystyrene sulfonate powder, 2 took placebo, and 2 took positive control drug （lanthanum carbonate）
干预措施: Lanthanum Polystyrene Sulphonate Powder (Drug)
group 4:dose 6g
There were 12 subjects in the group, 8 of whom took lanthanum polystyrene sulfonate powder, 2 took placebo, and 2 took positive control drug （lanthanum carbonate）
干预措施: Lanthanum Carbonate 500 MG (Drug)
group 4:dose 6g
There were 12 subjects in the group, 8 of whom took lanthanum polystyrene sulfonate powder, 2 took placebo, and 2 took positive control drug （lanthanum carbonate）
干预措施: Placebo (Drug)
结局指标
主要结局
Blood phosphate concentrations
时间窗: At pre-defined intervals from initial dose through final study visit（Day -1 to Day 17）
Plasma lanthanum concentrations
时间窗: At pre-defined intervals from initial dose through final study visit（Day -1 to Day 17）
次要结局
- 24h Urinary phosphate concentrations(At pre-defined intervals from initial dose through final study visit（Day 1 to Day 13）)
- Plasma PTH concentrations(At pre-defined intervals from initial dose through final study visit（Day 1 to Day 17）)
- Plasma calcium concentrations(At pre-defined intervals from initial dose through final study visit（Day 1 to Day 17）)