A Randomized, Double-Blind, Multi-Regional, Phase 3 Study to Evaluate the Efficacy and Safety of AP301 on Serum Phosphorus Control in Chronic Kidney Disease Patients Receiving Maintenance Dialysis With Hyperphosphatemia
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 264
- 试验地点
- 68
- 主要终点
- Change in serum phosphate concentrations in the AP301 and the AP301 low dose groups
研究概览
简要总结
The goal of this clinical trial is to learn if AP301 could work in the patients receiving maintenance dialysis with elevated blood phosphate. The main questions it aims to answer are:
- Does AP301 lower blood phosphate levels?
- Does AP301 works on serum calcium level, calcium times phosphate level, and intact parathyroid hormone level?
- What discomfort or medical problem do the patients have when taking AP301?
- Does AP301 improve quality of life in Chinese patients?
The researchers will compare AP301 to an ineffective comparator (a look-alike substance that contains low dose AP301) to see if AP301 works to treat elevated blood phosphate.
In the study, the patients will experience the following stages in a chronicle order:
- Stop all using blood phosphate-lowering drugs,
- Take AP301 or the comparator three times a day for 8 weeks,
- Take AP301 three times a day for 24 weeks, and
- Take AP301 or the comparator three times a day for 3 weeks.
In the first 32 weeks, the dose of AP301 will be adjusted upwards or downwards based on the patient's blood phosphate level and the study doctor's judgment.
If the participant has a blood phosphate level above or below a certain level, they may receive additional treatment to lower the blood phosphate level.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated ICF
- •Age ≥ 12 years when signing the ICF
- •Patients on dialysis for ≥ 3 months before signing the ICF and throughout the study
- •For HD patients, spKt/V ≥ 1.2; for PD patients, total Kt/V ≥ 1.7/week
- •Patients who receive phosphate-lowering drugs over 4 weeks and their serum phosphate level is:
- •Screening: 1.13 mmol/L (3.5 mg/dL) ≤ serum phosphate < 2.58 mmol/L (8.0 mg/dL)
- •After washout: 1.94 mmol/L (6.0 mg/dL) ≤ serum phosphate < 3.23 mmol/L (10.0 mg/dL)
排除标准
- •History or plan of kidney transplantation
- •History or plan of parathyroid intervention 6 months before signing the ICF
- •Serum calcium < 1.9 mmol/L (7.6 mg/dL) or > 2.75 mmol/L (11 mg/dL) at screening
- •Serum intact parathyroid hormone > 127 pmol/L (1200 pg/mL) at screening
- •Presence of clinically significant gastrointestinal (GI) disorder
- •History of gastrectomy or duodenectomy, or GI surgery within 3 months before signing the ICF
- •Known allergic to any ingredient of AP301, or known history of severe allergies leading to emergency medical care
- •Female who are breastfeeding
研究组 & 干预措施
AP301
A blood phosphate-lowering medication containing iron
干预措施: AP301 (Drug)
AP301 Low Dose
A blood phosphate-lowering medication containing iron, but with a low dose considered as ineffective
干预措施: AP301 Low Dose (Drug)
结局指标
主要结局
Change in serum phosphate concentrations in the AP301 and the AP301 low dose groups
时间窗: From Baseline to the end of Week 8
The amount of phosphate in the blood will be measured with a standard laboratory test. The change in phosphate levels will be compared between the group receiving AP301 and the group receiving AP301 low dose.
次要结局
- Chang in serum phosphate concentrations in the AP301 maintenance dose and the AP301 low dose groups(From the beginning of Week 33 to the end of Week 35)
- Change in serum phosphate concentrations over time throughout the study(From Baseline to the end of Week 35)
- Change in serum calcium (Ca) and intact parathyroid hormone levels over time(From Baseline to the end of Week 35)
- Number of adverse events(From Baseline to Follow-up (Up to 37 weeks))
- Change in QT intervals measured by 12-lead electrocardiagram test over time(From Baseline to the end of Week 35)