A Study to Investigate the Safety and Efficacy of ZS in Patients With Hyperkalemia
Condition: Hyperkalemia
MeSH terms: Hyperkalemia
Intervention: Sodium Zirconium Cyclosilicate (ZS) 10g; Sodium Zirconium Cyclosilicate (ZS) 5g; Sodium Zirconium Cyclosilicate (ZS) 10g; Placebo
Intervention description: Suspension administered 10g orally three times per day, in the first 48-hour of the study for all patients (48-hour open label initial phase); Suspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase.; Suspension administered 10g orally once daily for 28 days after the first 48-hour open label initial phase.; Suspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 267.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy of two different doses (5 and 10 g) of ZS orally administered once
      daily (qd) vs placebo in maintaining normokalemia in initially hyperkalemic patients having
      achieved normokalemia following two days of initial ZS therapy (10g TID).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of informed consent prior to any study specific procedures

          -  Female and male patients aged ≥18 and ≤ 90 years

          -  Two consecutive i-STAT potassium values, measured 60-minutes (± 10 minutes) apart,
             both ≥ 5.1 mmol/l 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:

          -  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