Open-label Safety and Efficacy of Sodium Zirconium Cyclosilicate for up to 12 Months

Completed · Phase 3

Conditions studied: Hyperkalemia

In brief

The Open-Label Maintenance Study contains an Acute Phase, in which subjects will be dosed with ZS 10 g three times daily (tid) for 24 to 72 hours, followed by a long-term Maintenance Phase.

Key facts

Study ID

NCT02163499

Run by

ZS Pharma, Inc.

People needed

751

Starts

2014-06-30

Expected to finish

2016-11-30

Last updated by the study team

2018-06-27

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 (+/- 15) minutes apart, both >/= 5.1 mmol/L and measured within 1 day before the first dose of ZS on Acute Phase Study Day 1.
• Ability to have repeated blood draws or effective venous catheterization.
• Women of childbearing potential must be using 2 forms of medically acceptable contraception (at least 1 barrier method) and have a negative pregnancy test at Acute Phase Study Day 1. Women who are surgically sterile or those who are postmenopausal for at least 2 years are not considered to be of childbearing potential.
• Controlled diabetic subjects.

You may not qualify if…

• Pseudohyperkalemia signs and symptoms, such as hemolyzed blood specimen due to excessive fist clenching to make veins prominent, difficult or traumatic venipuncture, or history of severe leukocytosis or thrombocytosis.
• Subjects treated with lactulose, rifaximin, or other non-absorbed antibiotics for hyperammonemia within 7 days prior to first dose of ZS on Acute Phase Study Day 1.
• Subjects treated with sodium polystyrene sulfonate (SPS; eg, Kayexalate®) or calcium polystyrene sulfonate (eg, Resonium®) within 3 days prior to first dose of ZS on Acute Phase Study Day 1.
• Subjects with a life expectancy of less than 12 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.
• 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.
• Subjects randomized into the previous ZS-002, ZS-003, ZS-004, or ZS-004E studies.
• Documented GFR <15 mL/min within 90 days prior to study entry.

Where it is running

• Study site — Scottsboro, Alabama, United States
• Study site — Tempe, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Chula Vista, California, United States
• Study site — Los Angeles, California, United States
• Study site — Paramount, California, United States
• Study site — Riverside, California, United States
• Study site — Sacramento, California, United States
• Study site — Whittier, California, United States
• Study site — Denver, Colorado, United States
• Study site — Brandon, Florida, United States
• Study site — DeLand, Florida, United States
• Study site — Hudson, Florida, United States
• Study site — Lauderdale Lakes, Florida, United States
• Study site — Miami, 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 — Tampa, Florida, United States
• Study site — Winter Park, Florida, United States
• Study site — Columbus, Georgia, United States
• Study site — Evergreen Park, Illinois, United States
• Study site — Joliet, Illinois, United States
• Study site — Paducah, Kentucky, United States
• Study site — Shreveport, Louisiana, United States

Full record on ClinicalTrials.gov

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