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

Completed · Phase 3 · Has a placebo group

Conditions studied: Hyperkalemia

In brief

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).

Key facts

Study ID

NCT02088073

Run by

ZS Pharma, Inc.

People needed

258

Starts

2014-03-31

Expected to finish

2015-01-31

Last updated by the study team

2018-12-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Anniston, Alabama, United States
• Study site — Huntsville, Alabama, United States
• Study site — Scottsboro, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tempe, Arizona, United States
• Study site — Hawaiian Gardens, California, United States
• Study site — Los Angeles, California, United States
• Study site — Paramount, California, United States
• Study site — Riverside, California, United States
• Study site — Atlantis, Florida, United States
• Study site — Bradenton, Florida, United States
• Study site — Brandon, Florida, United States
• Study site — Brooksville, Florida, United States
• Study site — DeLand, Florida, United States
• Study site — Edgewater, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Miami Lakes, Florida, United States
• Study site — New Smyrna Beach, Florida, United States
• Study site — Ocala, Florida, United States
• Study site — Summerfield, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Winter Park, Florida, United States
• Study site — Columbus, Georgia, United States
• Study site — Decatur, Georgia, United States
• Study site — Evergreen Park, Illinois, United States

Full record on ClinicalTrials.gov

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