NCT05764590已完成2 期
A Phase 2, Randomized, Open-Label, Active-Controlled, Multicenter Study to Evaluate the Safety and Serum Phosphorus Lowering Effect of AP-306 in Chronic Kidney Disease Patients Receiving Maintenance Hemodialysis With Hyperphosphatemia
Alebund Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2023年2月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of AP-306 assessed by serum phosphorus lowering
研究概览
简要总结
The goal of this clinical trial is to learn about the following questions in the patients receiving maintenance hemodialysis with elevated blood phosphorus:
- How much effect AP-306 has assessed by blood phosphorus lowering;
- How safe and tolerable AP-306 is.
Participants will receive either following treatments:
- AP-306, and
- Sevelamer carbonate.
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
- •On a stable hemodialysis regimen at a frequency of three times per week for at least 12 weeks prior to the screening visit
- •Dialysis sufficiency SpKt/V ≥ 1.2 at the screening visit or any documented result within 12 weeks prior to the screening visit
- •Serum phosphorus within the trial-required range
排除标准
- •Pregnant or breastfeeding
- •Any history of kidney transplant
- •Any history of a parathyroid intervention
- •Any clinically significant GI disorders within 4 weeks prior to the screening visit
- •Hospitalization for cardiac or cerebrovascular disease within 24 weeks prior to the screening visit
- •Hospitalization for cardiac or cerebrovascular disease within 24 weeks prior to the screening visit
- •Documented history of hypersensitivity or allergic reactions to any of the excipients used by AP-306, or history of hypersensitivity or allergic reactions or intolerant to sevelamer carbonate
研究组 & 干预措施
AP-306
Experimental
干预措施: AP-306 (Drug)
Sevelamer Carbonate
Active Comparator
干预措施: Sevelamer Carbonate (Drug)
结局指标
主要结局
To evaluate the efficacy of AP-306 assessed by serum phosphorus lowering
时间窗: 12 weeks
The change in serum phosphorus level from the baseline to the end of treatment
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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