Open-label Safety & Efficacy of ZS (Sodium Zirconium Cyclosilicate)10g qd to Extend Study ZS-004 in Hyperkalemia.
Condition: Hyperkalemia
MeSH terms: Hyperkalemia
Intervention: Sodium Zirconium Cyclosilicate
Intervention description: Oral 10g once daily with breakfast for 11 months.
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Subjects who completed the Double-blind Randomized Maintenance Phase (DBRMP) Study Day 29
      visit in ZS-004 (NCT 02088073) and have an i-STAT potassium value that is 3.5 to 6.2 mmol/l
      inclusive or who discontinued during ZS-004 due to hypo- or hyperkalemia in the DBRMP and
      have a mean i-STAT potassium value from two consecutive measurements at 0 and 60 minutes on
      Acute Phase Day 1/Maintenance Phase Day 1 that is 3.5 to 6.2 mmol/l inclusive may have the
      option to participate in ZS-004E (NCT 021070920). Subjects who discontinued from study ZS-004
      due to any other reasons (e.g. adverse events, poor compliance, investigator decision) will
      not be entered into study ZS-004E. All subjects who continue into the extension study must
      begin dosing within two (2) days after the last dose of investigational product in ZS-004.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of written informed consent.

          -  Completed the ZS-004 DBRMP Study Day 29 visit or discontinued study ZS-004 during the
             DBRMP due to hypo- or hyperkalemia and able to start dosing in ZS-004E within two (2)
             days after the last dose of Investigational product in ZS-004.

          -  Subject must have an i-STAT potassium value that is 3.5 to 6.2 mmol/l inclusive at the
             ZS-004 DBRMP Study Day 29 visit or a mean i-STAT potassium value from two consecutive
             measurements at 0 and 60 minutes on Acute Phase Day 1/Maintenance Phase Day 1 that is
             3.5 to 6.2 mmol/l inclusive if the subject discontinued study ZS-004 during the DBRMP
             due to hypo- or hyperkalemia .

        Exclusion Criteria:

          -  Pseudohyperkalemia signs and symptoms, such as excessive fist clenching hemolyzed
             blood specimen, history of severe leukocytosis or thrombocytosis.

          -  Subjects who received alternative treatment for hyperkalemia while participating in
             study ZS-004.

          -  Subjects with a life expectancy of less than 3 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 other than ZS 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.