Safety & Efficacy of Zirconium Silicate Dosed for 28 Days in Hyperkalemia.

• Status: Completed
• Trial end date: 2015-01-31
• Target enrollment: 0
• Participant gender: All

Summary

It is hypothesized that ZS is more effective than placebo control (alternative hypothesis) in maintaining mean double-blind randomized maintenance phase (DBRMP) Day 8-29 serum potassium levels (3.5 - 5.0 mmol/l, inclusive) among hyperkalemic subjects in whom normokalemia was established during the open-label acute phase versus no difference between each ZS dose (highest to lowest) versus placebo control (null hypothesis).

• 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.

• Two consecutive i-STAT potassium values, measured 60-minutes apart, both ≥5.1 mmol/l and measured within 1 day of the first ZS dose on AP Study Day 1.

• 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 AP Study Day 1. Women who are surgically sterile or those who are post-menopausal for at least 2 years are not considered to be of childbearing potential.

Exclusion Criteria:

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

• Subjects treated with lactulose, Xifaxan or other non-absorbed antibiotics for hyperammonemia within 7 days prior to the first dose of study drug.

• Subjects treated with resins (such as sevelamer acetate or sodium polystyrene sulfonate [SPS; e.g. Kayexalate®]), calcium acetate, calcium carbonate, or lanthanum carbonate, within 7 days prior to the first dose of study drug.

• 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.

• Randomization into the previous ZS-002 or ZS-003 studies.

• 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 dialysis.