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

NCT02107092 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: ZS-004E
• Study Type: interventional
• Target: 123
• Locations: 3 countries
• Sites: 49

Brief Summary

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.

Conditions

Hyperkalemia

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects With Average Serum Potassium Values ≤ 5.1 mmol/L

  The proportions of subjects with average serum potassium (S-K) values ≤ 5.1 mmol/L during Extended Dosing Study Days 8 to 337, inclusive

  11 months

Secondary Outcomes (1)

• Proportion of Subjects With Average Serum Potassium Values ≤ 5.5 mmol/L

  11 months

Study Arms (1)

Sodium Zirconium Cyclosilicate

EXPERIMENTAL

Open label oral administration of sodium zirconium cyclosilicate 10g once daily for 11 months.

Drug: Sodium Zirconium Cyclosilicate

Interventions

Sodium Zirconium Cyclosilicate DRUG

Oral 10g once daily with breakfast for 11 months.

Also known as: ZS

Sodium Zirconium Cyclosilicate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• ZS Pharma, Inc.: lead

Study Sites (49)

Unknown Facility

Anniston, Alabama, 36207, United States

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Huntsville, Alabama, 35801, United States

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Scottsboro, Alabama, 35768, United States

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Phoenix, Arizona, 85027, United States

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Tempe, Arizona, 85284, United States

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Hawaiian Gardens, California, 90716, United States

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Los Angeles, California, 90022, United States

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Paramount, California, 90723, United States

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Riverside, California, 92505, United States

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Atlantis, Florida, 33462, United States

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Bradenton, Florida, 34208, United States

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Brandon, Florida, 33511, United States

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Brooksville, Florida, 34601, United States

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DeLand, Florida, 32720, United States

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Edgewater, Florida, 32132, United States

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Miami, Florida, 33015, United States

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Miami, Florida, 33125, United States

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Miami Lakes, Florida, 33014, United States

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Miami Lakes, Florida, 33018, United States

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New Smyrna Beach, Florida, 32168, United States

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Ocala, Florida, 34471, United States

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Summerfield, Florida, 34491, United States

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Tampa, Florida, 33607, United States

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Tampa, Florida, 33614, United States

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Winter Park, Florida, 32789, United States

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Columbus, Georgia, 31901, United States

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Decatur, Georgia, 30030, United States

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Evergreen Park, Illinois, 60805, United States

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Joliet, Illinois, 60435, United States

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Shreveport, Louisiana, 71101, United States

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Auburn, Maine, 04210, United States

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Chesterfield, Michigan, 48047, United States

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Kansas City, Missouri, 64411, United States

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Las Vegas, Nevada, 89115, United States

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Flushing, New York, 11355, United States

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Altoona, Pennsylvania, 16602, United States

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Providence, Rhode Island, 02903, United States

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Orangeburg, South Carolina, 29118, United States

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Sumter, South Carolina, 29150, United States

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Chattanooga, Tennessee, 37408, United States

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San Antonio, Texas, 78229, United States

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Gosford, New South Wales, Australia

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Woolloongabba, Queensland, Australia

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Heidelberg, Victoria, Australia

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Melbourne, Victoria, Australia

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Parkville, Victoria, Australia

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Meyerspark, South Africa

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Port Elizabeth, South Africa

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Somerset West, South Africa

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MeSH Terms

Conditions

Hyperkalemia

Interventions

sodium zirconium cyclosilicate

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: AstraZeneca Clinical Study Information Center
• Organization: ZS Pharma, Inc.

information.center@astrazeneca.com

1-877-240-9479

Study Officials

• Henrik Rasmussen, MD, PhD

  ZS Pharma, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2014
• First Posted: April 8, 2014
• Study Start: May 31, 2014
• Primary Completion: July 31, 2015
• Study Completion: August 31, 2015
• Last Updated: August 15, 2018
• Results First Posted: August 15, 2018

Record last verified: 2018-07

Locations

US (41); AU (5); ZA (3)