Open-label Safety and Efficacy of Sodium Zirconium Cyclosilicate for up to 12 Months

Inclusion Criteria

• Inclusion Criteria:
• - Provision of written informed consent.
• - Over 18 years of age.
• - Two consecutive i STAT potassium values, measured 60 (+/- 15) minutes
• apart, both >/= 5.1 mmol/L and measured within 1 day before the first
• dose of ZS on Acute Phase Study Day 1.
• - Ability to have repeated blood draws or effective venous catheterization.
• - Women of childbearing potential must be using 2 forms of medically
• acceptable contraception (at least 1 barrier method) and have a negative
• pregnancy test at Acute Phase Study Day 1. Women who are surgically
• sterile or those who are postmenopausal for at least 2 years are not
• considered to be of childbearing potential.
• - Controlled diabetic subjects.
• Exclusion Criteria:
• - Pseudohyperkalemia signs and symptoms, such as hemolyzed blood
• specimen due to excessive fist clenching to make veins prominent,
• difficult or traumatic venipuncture, or history of severe leukocytosis or
• thrombocytosis.
• - Subjects treated with lactulose, rifaximin, or other non-absorbed
• antibiotics for hyperammonemia within 7 days prior to first dose of ZS on
• Acute Phase Study Day 1.
• - Subjects treated with sodium polystyrene sulfonate (SPS; eg,
• Kayexalate®) or calcium polystyrene sulfonate (eg, Resonium®) within 3
• days prior to first dose of ZS on Acute Phase Study Day 1.
• - Subjects with a life expectancy of less than 12 months.
• - Subjects 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.
• - Women who are pregnant, lactating, or planning to become pregnant.
• - Subjects with diabetic ketoacidosis.
• - Presence of any condition which, in the opinion of the investigator, places
• the subject 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.
• - Treatment with a drug or device within the last 30 days that has not
• received regulatory approval at the time of study entry.
• - Subjects with cardiac arrhythmias that require immediate treatment.
• - Subjects on dialysis.
• - Subjects randomized into the previous ZS-002, ZS-003, ZS-004, or ZS-004E studies.
• - Documented GFR <15 mL/min within 90 days prior to study entry.