ZG-801 Phase III Trial - Randomized, Double-blind, Placebo-controlled Trial of ZG-801 in patients with Hyperkalemia -

Zeria Pharmaceutical Co., Ltd.0 个研究点目标入组 100 人开始时间: 2021年8月3日最近更新: 2025年6月17日

适应症

试验速览

暂无简介。

•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.

•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.
•a) Sodium polystyrene sulfonate
•b) Calcium polystyrene sulfonate
•c) Sodium zirconium cyclosilicate hydrate
•d) Potassium supplement
•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.
•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)

Change in serum potassium value at Double-blind period week4

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发起方