NCT04955678已完成3 期
ZG-801 Phase III Trial - Randomized, Double-blind, Placebo-controlled Trial of ZG-801 in Patients With Hyperkalemia -
Zeria Pharmaceutical1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2021年8月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Change in serum potassium value at Double-blind period week4
研究概览
简要总结
The purpose of this study is to evaluate the superiority of ZG-801 to placebo in Japanese hyperkalemia patients whose serum potassium value becomes normal in the Run-in period by comparing the change in the value at the Double-blind period week 4, and to further evaluate the efficacy and safety of ZG-801 in Japanese hyperkalemia patients administrated ZG-801 for maximum 9 weeks.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients whose serum potassium value (local) at the Run-in period baseline is ≥5.5mEq/L, < 6.5 mEq/L
- •Age 20 - 80 years old at informed consent
- •Patients who understand an overview of the study and voluntarily consented to participate in the study by documents.
排除标准
- •Patients determined to require emergency treatment for hyperkalemia at the Run-in period baseline
- •Patients with poorly controlled blood pressure
- •Patients with heart failure in New York Heart Association Class IV
- •Patients who have experienced heart transplant, liver transplant or kidney transplant or who are predicted that the need for them will occur during the study
- •Patients who have taken any of the following medication within 7 days prior to the Run-in period baseline or currently administrated.
- •Sodium polystyrene sulfonate
- •Calcium polystyrene sulfonate
- •Sodium zirconium cyclosilicate hydrate
- •Potassium supplement
- •Patients with or who have experienced a severe swallowing disorder, moderate to severe gastroparesis, severe constipation, bowel obstruction, incarceration, abnormal post-operative bowel motility disorders or severe gastrointestinal disorders. In addition, patients who have experienced bariatric surgery or major gastrointestinal surgery (e.g., bowel resection).
- •Patients suspected to be with transient high potassium value.(ex. caused by dietary effects only)
研究组 & 干预措施
ZG-801
Experimental
干预措施: Calcium, hydrolysed divinylbenzene-Me 2-fluoro-2-propenoate-1, 7-octadiene polymer sorbitol complexes (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in serum potassium value at Double-blind period week4
时间窗: Double-blind period baseline to Double-blind period week4
次要结局
- Time to First Non-maintenance of Serum Potassium Value in Double-blind Period(Double-blind period baseline to Double-blind period week4)
- Change in Serum Potassium Value(Run-in period baseline to Run-in period week 5)
- Maintenance of serum potassium value within 3.5 mEq/L to < 5.1 mEq/L or within 3.5 mEq/L to <5.5 mEq/L in Double-blind Period(Double-blind period baseline to Double-blind period week4)
- RAASi dose sustaining proportion(Double-blind period baseline to Double-blind period week4)
研究者
研究点 (1)
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