Study to Evaluate the Efficacy and Safety of PT20 in Subjects With Hyperphosphataemia and Dialysis Dependent Chronic Kidney Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 153
- 主要终点
- Change in Serum Phosphate Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)
研究概览
简要总结
The main purpose of this study is to see whether PT20 can help people with a high level of phosphate in their blood (called Hyperphosphatemia) that are being treated with dialysis for kidney disease.
详细描述
PT20 represents a mechanism to address many of the limitations associated with current phosphate binding agents. The available clinical and non clinical evidence suggests that PT20 binds phosphate and prevents its uptake more efficiently than other phosphate binding drugs and may therefore either reduce the pill burden associated with controlling phosphate levels, or result in lower phosphate levels with the same pill burden.
The this study is the first to investigate the efficacy and safety of PT20 in subjects with dialysis-dependent chronic kidney disease (CKD).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged 18 90 years
- •Subject must have a stable dialysis prescription for at least 28 days prior to start of Screening.
- •Subject must have the most recent serum phosphate measurement, taken during the 28 days prior to the start of Screening, of ≥ 4.0 mg/dL and ≤ 8 mg/dL.
排除标准
- •Subject's most recent historical pre-dialysis serum bicarbonate value within 14 days prior to the start of Screening (Visit 1) is < 18 mg/dL.
- •Subject has, in the opinion of the investigator, severe chronic lung disease and/or carbon dioxide retention.
研究组 & 干预措施
Group 1 - PT20 400 mg tid
PT20 400 mg tid (1.2 g/day) administered orally.
Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study
干预措施: PT20 (Drug)
Group 2 - PT20 800 mg tid
PT20 800 mg tid (2.4 g/day) administered orally.
Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study
干预措施: PT20 (Drug)
Group 3 - PT20 1600 mg tid
PT20 1600 mg tid (4.8 g/day) administered orally.
Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study
干预措施: PT20 (Drug)
Group 4 - PT20 3200 mg tid
PT20 3200 mg tid (9.6 g/day) administered orally.
Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study
干预措施: PT20 (Drug)
Group 5 - Placebo tid
Matched Placebo (for PT20) tid administered orally.
Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Serum Phosphate Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)
时间窗: Day 1 to Day 29
The primary efficacy endpoint was the change in serum phosphate concentration from Baseline (Visit 7, Day 1) to Visit 11 (Day 29). All study specific blood samples were collected, processed and analysed using a central laboratory.
次要结局
- Change in Serum Ferritin Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)(Day 1 to Day 29)
- Change in Haemoglobin Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)(Day 1 to Day 29)
- Change in Calcium x Phosphate Product From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)(Day 1 to Day 29)
- Change in Transferrin Saturation From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)(Day 1 to Day 29)
- Change in Gastrointestinal Symptom Rating System (GSRS) Overall Score From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)(Day 1 to Day 29)