Safety & Efficacy of Zirconium Silicate in Mild to Moderate Hyperkalemia

• Status: Completed
• Trial end date: 2013-11-30
• Target enrollment: 0
• Participant gender: All

Summary

Acute Phase: It is hypothesized that ZS (zirconium silicate) is more effective than placebo control (alternative hypothesis) in lowering S-K levels in subjects with S-K between 5.0 - 6.5 mmol/l versus no difference between ZS and placebo control (null hypothesis).

Subacute Phase (randomized withdrawal): It is hypothesized that ZS once daily is more effective than placebo control (alternative hypotheses) in maintaining normokalemic levels (3.5 - 4.9 mmol/l) among subjects completing the Acute Phase versus no difference between each ZS dose and respective placebo controls (null hypotheses).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ZS Pharma, Inc.

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).

• Ability to have repeated blood draws or effective venous catheterization.

• Women of childbearing potential must be practicing a highly effective method of birth control.

Exclusion Criteria:

• Pseudohyperkalemia signs and symptoms, such as excessive fist clinching hemolyzed blood specimen, severe leukocytosis or thrombocytosis.

• Subjects treated with lactulose, xifaxan or other nonabsorbed antibiotics for hyperammonemia within the last 7 days.

• Subjects treated with resins (such as Sevelamer acetate or Sodium polystyrene sulfonate [SPS; e.g. Kayexalate®]), calcium acetate, calcium carbonate, or lanthanum carbonate, within the last 7 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 Ketoacidosis/Acidemia.

• 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 ZS

• 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.

• Insulin-dependent diabetes mellitus

• Subjects on dialysis