Open-label Safety of Sodium Zirconium Cyclosilicate for up to 12 Months in Japanese Subjects With Hyperkalemia
Condition: Hyperkalemia
MeSH terms: Hyperkalemia
Intervention: Zirconium Cyclosilicate
Intervention description: Correction Phase Dosing: Sodium Zirconium Cyclosilicate 10 g three times daily (TID) from 24 to 72 Extended Dosing: Sodium Zirconium Cyclosilicate 5 g once daily (QD). Sodium Zirconium Cyclosilicate dose increased or decreased in increments/decrements of 5 g QD up to a maximum of 15 g QD or a minimum of 5 g every other day (QOD) (or 2.5 g QD) based on i-STAT potassium measurements up to 12 months.
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No

Summary:

      The Open-Label Maintenance Study contains an Correction Phase, in which subjects will be
      dosed with ZS 10 g three times daily (tid) for 24 to 72 hours, followed by a 12-month
      long-term Maintenance Phase.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of informed consent prior to any study specific procedures.

          -  Patients aged ≥18. For patients aged <20 years, a written informed consent should be
             obtained from the patient and his or her legally acceptable representative.

          -  Two consecutive i-STAT potassium values, measured 60-minutes (± 15 minutes) apart,
             both ≥ 5.1 mmol/L and measured within 1 day before the first dose of ZS on Correction
             Phase Study Day 1.

          -  Patients who are on peritoneal dialysis (PD) can be enrolled if their SK level is ≥5.5
             and ≤ 6.5 mmol/L in two consecutive i-STAT potassium evaluation at least 24 hours
             apart before Day 1 (in each evaluation, two i-STAT potassium measurements at least 1
             hour apart are required). i-STAT potassium measurement should be performed in the
             morning before breakfast and in the evening before dinner in PD patients on continuous
             ambulatory peritoneal dialysis (CAPD) and automated peritoneal dialysis (APD),
             respectively.

          -  Women of childbearing potential must be using 2 forms of medically acceptable
             contraception (at least 1 barrier method) and have a negative pregnancy test within 1
             day prior to the first dose of ZS on Correction Phase Study Day 1. Women who are
             surgically sterile or those who are postmenopausal for at least 1 year are not
             considered to be of childbearing potential.

        Exclusion Criteria:

          -  Patients treated with lactulose, rifaxan (rifaximin), or other non-absorbed
             antibiotics for hyperammonemia within 7 days prior to first dose of ZS.

          -  Patients treated with resins (such as sevelamer hydrochloride, sodium polystyrene
             sulfonate [SPS; e.g. Kayexalate®] or calcium polystyrene sulfonate [CPS]), calcium
             acetate, calcium carbonate, or lanthanum carbonate, within 7 days prior to the first
             dose of study drug. Washout of SPS and CPS for 7 days (or longer) prior to the first
             dose of ZS is allowed, if termination of CPS or SPS is judged to be clinically
             acceptable by the investigator. Documented informed consent has to be obtained prior
             to the washout.

          -  Patients with a life expectancy of less than 12 months

          -  Female patients who are pregnant, lactating, or planning to become pregnant

          -  Patients who have an active or history of diabetic ketoacidosis

          -  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.

          -  Patients with cardiac arrhythmias that require immediate treatment

          -  Hemodialysis patients (including those who are on both PD and hemodialysis [HD])

          -  Patients who have been on PD less than 6 months or more than 6 months with a history
             of hypokalemia within 6 months before Correction Phase Day 1

          -  Documented Glomerular Filtration Rate (GFR) < 15 mL/min within 90 days prior to study
             entry (Non peritoneal dialysis (PD) patients only)

          -  If patients joined ZS study in the past, the patients cannot join this study within
             the last 30 days of the last study drug administration day.