Safety and Efficacy of Sodium Polystyrene Sulfonate in Hyperkalemia
Condition: Hyperkalemia
MeSH terms: Hyperkalemia
Intervention: Sodium polystyrene sulfonate; Silicified microcrystalline cellulose
Intervention description: Oral suspension in water of 15g sodium polystyrene sulfonate administered three times (tid) daily for 48 hours without co-administration of Sorbitol.; Oral suspension in water of placebo administered three times (tid) daily for 48 hours.
Intervention MeSH terms: Polystyrene sulfonic acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      It is hypothesized that SPS is more effective than placebo control (alternative hypothesis)
      in lowering i-STAT potassium levels in subjects with i-STAT potassium levels between 5.0 -
      6.5 mmol/l versus no difference between SPS and placebo control (null hypothesis).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of written informed consent.

          -  Over 18 years of age.

          -  Mean i-STAT potassium values between 5.0 - 6.5 mmol/l inclusive, at screening (Study
             Day 0).

          -  Previous participation in Clinical ZS-002 or ZS-003 protocol(s). However, subjects
             cannot be enrolled in this study until at least 30 days have elapsed from their last
             dose in study ZS-003.

          -  Ability to have repeated blood draws or effective venous catheterization.

          -  Women of childbearing potential must be using two forms of medically acceptable
             contraception (at least one barrier method) and have a negative pregnancy test at
             screening.

        Women who are surgically sterile or those who are post-menopausal for at least 2 years are
        not considered to be of child-bearing potential.

        Exclusion Criteria:

          -  Pseudohyperkalemia signs and symptoms, such as excessive fist clenching hemolyzed
             blood specimen, severe leukocytosis or thrombocytosis.

          -  Subjects treated with lactulose, Xifaxan or other non-absorbed antibiotics for
             hyperammonemia within the last 7 days.

          -  Subjects treated with resins (such as Sevelamer acetate), calcium acetate, calcium
             carbonate, or lanthanum carbonate, within the last 7 days.

          -  Subjects treated with Sodium Polystyrene Sulfonate (SPS; e.g. Kayexalate®) or ZS
             (microporous, fractionated, protonated zirconium silicate) within the last 30 days.

          -  Subjects with a life expectancy of less than 3 months.

          -  Subjects who are HIV positive.

          -  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.

          -  Previous treatment with SPS.

          -  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 insulin where a stable dose has not yet been established.*

          -  Subjects on dialysis. * Subjects on stable insulin or insulin analogues can be
             enrolled. Subjects who have been on the same insulin dose and regimen for > 14 days
             are considered stable. Whenever possible, all blood draws collected prior to meals
             should be collected prior to insulin/insulin analogue treatment.