JPRN-jRCT2031210188已完成3 期
ZG-801 Phase III Trial - Randomized, Double-blind, Placebo-controlled Trial of ZG-801 in patients with Hyperkalemia
Tomioka Yuusuke0 个研究点目标入组 100 人开始时间: 2021年7月9日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •1) Patients whose serum potassium value (local) at the Run-in period baseline is >=5.5mEq/L, < 6.5 mEq/L
- •2) Age 20 - 80 years old at informed consent
- •3) Patients who understand an overview of the study and voluntarily consented to participate in the study by documents.
排除标准
- •1) Patients determined to require emergency treatment for hyperkalemia at the Run-in period baseline
- •2) Patients with poorly controlled blood pressure
- •3) Patients with heart failure in New York Heart Association Class IV
- •4) 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
- •5) Patients who have taken any of the following medication within 7 days prior to the Run-in period baseline or currently administrated.
- •a) Sodium polystyrene sulfonate
- •b) Calcium polystyrene sulfonate
- •c) Sodium zirconium cyclosilicate hydrate
- •d) Potassium supplement
- •6) Patients whose last measured eGFR within 90 days prior to the Run-in period baseline is >= 60mEq/L (calculated by using the serum creatinine value measured at local laboratory). When eGFR has not been measured within 90 days prior to the Run-in period baseline, it must be measured until the Run-in period baseline.
- •7) 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).
- •8) Patients suspected to be with transient high potassium value.(ex. caused by dietary effects only)
研究者
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