Hyperkalemia
Conditions
Interventions
investigational material(s)
Generic name etc : Sodium Zirconium Cyclosilicate (ZS) 10g, Sodium Zirconium Cyclosilicate (ZS) 5g
INN of investigational material :
Therapeutic category code : 219 Other
Sponsors
AstraZeneca
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
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
Outcome results
None listed