Open-label Safety & Efficacy of ZS (Sodium Zirconium Cyclosilicate)10g qd to Extend Study ZS-004 in Hyperkalemia.

Completed · Phase 3

Conditions studied: Hyperkalemia

In brief

Subjects who completed the Double-blind Randomized Maintenance Phase (DBRMP) Study Day 29 visit in ZS-004 (NCT 02088073) and have an i-STAT potassium value that is 3.5 to 6.2 mmol/l inclusive or who discontinued during ZS-004 due to hypo- or hyperkalemia in the DBRMP and have a mean i-STAT potassium value from two consecutive measurements at 0 and 60 minutes on Acute Phase Day 1/Maintenance Phase Day 1 that is 3.5 to 6.2 mmol/l inclusive may have the option to participate in ZS-004E (NCT 021070920). Subjects who discontinued from study ZS-004 due to any other reasons (e.g. adverse events, poor compliance, investigator decision) will not be entered into study ZS-004E. All subjects who continue into the extension study must begin dosing within two (2) days after the last dose of investigational product in ZS-004.

Key facts

Study ID

NCT02107092

Run by

ZS Pharma, Inc.

People needed

123

Starts

2014-05-31

Expected to finish

2015-08-31

Last updated by the study team

2018-08-15

Who can join

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

You may qualify if…

• Provision of written informed consent.
• Completed the ZS-004 DBRMP Study Day 29 visit or discontinued study ZS-004 during the DBRMP due to hypo- or hyperkalemia and able to start dosing in ZS-004E within two (2) days after the last dose of Investigational product in ZS-004.
• Subject must have an i-STAT potassium value that is 3.5 to 6.2 mmol/l inclusive at the ZS-004 DBRMP Study Day 29 visit or a mean i-STAT potassium value from two consecutive measurements at 0 and 60 minutes on Acute Phase Day 1/Maintenance Phase Day 1 that is 3.5 to 6.2 mmol/l inclusive if the subject discontinued study ZS-004 during the DBRMP due to hypo- or hyperkalemia .

You may not qualify if…

• Pseudohyperkalemia signs and symptoms, such as excessive fist clenching hemolyzed blood specimen, history of severe leukocytosis or thrombocytosis.
• Subjects who received alternative treatment for hyperkalemia while participating in study ZS-004.
• 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.
• Treatment with a drug or device other than ZS 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, Florida, United States
• Study site — Miami Lakes, 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 — Tampa, Florida, United States
• Study site — Winter Park, Florida, United States

Full record on ClinicalTrials.gov

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