A Phase 3 Multicenter, Prospective, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety and Efficacy of ZS, in Patients With Hyperkalemia-HARMONIZE Global

AstraZeneca0 个研究点开始时间: 2017年3月24日最近更新: 2023年10月17日

研究概览

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•Provision of informed consent prior to any study specific procedures
•- Two consecutive i-STAT potassium values, measured 60-minutes apart, both 5.1 mmol/l or more and measured within 1 day of the first ZS dose on 48-hour open-label initial phase Day 1
•- Ability to have repeated blood draws or effective venous catheterization
•- Female patients must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception for the duration of the study and for 3 months after the last dose of ZS/matching placebo to prevent pregnancy

•- Involvement in the planning and/or conduct of the study
•- Participation in another clinical study with an investigational product during the last 3 months
•- Pseudohyperkalemia signs and symptoms
•- Patients treated with lactulose, xifaxan (rifaximin) or other non-absorbed antibiotics for hyperammonemia within 7 days prior to the first dose of study drug
•- Patients treated with resins,calcium acetate,calcium carbonate, or lanthanum carbonate,within 7 days prior to the first dose of study drug
•- Patients with a life expectancy of less than 3 months
•- Patients who are severely physically or mentally incapacitated and who in the opinion of investigator are unable to perform the subjects' tasks associated with the protocol
•- Female patients who are pregnant, lactating, or planning to become pregnant
•- Patients with diabetic ketoacidosis
•- Presence of any condition which, in the opinion of the investigator, places the patient at undue risk or potentially jeopardizes the quality of the data to be generated
•- Known hypersensitivity or previous anaphylaxis to ZS or to components thereof
•- Patients with cardiac arrhythmias that require immediate treatment
•- Patients on dialysis
•- Patients who are blood donors should not donate blood during the study and for 3 months following their last dose of ZS

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