A study to investigate the safety and efficacy of ZS in patients with hyperkalemia - HARMONIZE GL

Exclusion Criteria

• •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