- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02163499
Open-label Safety and Efficacy of Sodium Zirconium Cyclosilicate for up to 12 Months
Multicenter, Multi-Dose, Open-Label Maintenance of Long-Term Safety and Efficacy of Sodium Zirconium Cyclosilicate (ZS) in Hyperkalemia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Subjects with 2 consecutive i STAT potassium values 5.1 mmol/L will enter the Acute Phase and receive ZS 10 g tid for 24 to 72 hours, depending on potassium values. Once normokalemia (i STAT potassium between 3.5 and 5.0 mmol/L, inclusive) is restored (whether after 24, 48 or 72 hours), subjects will be enrolled in the Maintenance Phase to be dosed with ZS at a starting dose of 5 g qd. Potassium (i STAT and central laboratory) will be measured weekly throughout the first month of study and every 4 weeks thereafter through Month 12. During the Maintenance Phase, the ZS dose may be increased or decreased in increments/decrements of 5 g qd up to a maximum of 15 g qd or a minimum of 5 g every other day based on i STAT potassium measurements as outlined below:
• > 5.0 mmol/L while receiving 5 g qd or 5 g every other day or > 5.5 mmol/L while receiving 10 g qd: increase ZS dose in 5 g qd increments to a maximum dose of 15 g qd
.• Between 3.0 and 3.4 mmol/L, inclusive: decrease ZS dose in 5 g qd decrements to a minimum dose of 5 g every other day; if a subject's i STAT potassium value remains between 3.0 and 3.4 mmol/L, inclusive, on the ZS 5 g every other day dose, the subject will be withdrawn from the study and receive standard of care treatment.
There is no limit to the number of dose titrations allowed. Subjects will receive up to 12 months of treatment with open-label ZS.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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New South Wales
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Gosford, New South Wales, Australia, 2250
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Queensland
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Woolloongabba, Queensland, Australia, 4102
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Victoria
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Heidelberg, Victoria, Australia, 3084
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Melbourne, Victoria, Australia, 3073
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Parkville, Victoria, Australia, 3050
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Berlin, Germany, 13353
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Stuttgart, Germany, 70376
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Amsterdam, Netherlands, 1105 AZ
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Lasi, Romania, 700503
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Cape Town, South Africa, 7925
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Meyerspark, South Africa
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Port Elizabeth, South Africa, 6001
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Somerset West, South Africa, 7130
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Leicester, United Kingdom, LE1 9HN
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Alabama
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Scottsboro, Alabama, United States, 35768
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Arizona
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Tempe, Arizona, United States, 85284
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Tucson, Arizona, United States, 85724
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California
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Chula Vista, California, United States, 90717
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Los Angeles, California, United States, 90022
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Paramount, California, United States, 90723
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Riverside, California, United States, 92505
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Sacramento, California, United States, 95825
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Whittier, California, United States, 90603
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Colorado
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Denver, Colorado, United States, 80230
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Florida
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Brandon, Florida, United States, 33511
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DeLand, Florida, United States, 32720
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Hudson, Florida, United States, 34667
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Lauderdale Lakes, Florida, United States, 33313
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Miami, Florida, United States, 33125
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Miami, Florida, United States, 33015
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Miami Lakes, Florida, United States, 33018
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New Smyrna, Florida, United States, 32168
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New Smyrna Beach, Florida, United States, 32168
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Tampa, Florida, United States, 33614
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Winter Park, Florida, United States, 32789
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Georgia
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Columbus, Georgia, United States, 31901
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Illinois
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Evergreen Park, Illinois, United States, 60805
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Joliet, Illinois, United States, 60435
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Kentucky
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Paducah, Kentucky, United States, 42003
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Louisiana
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Shreveport, Louisiana, United States, 71101
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Michigan
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Chesterfield, Michigan, United States, 48047
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Missouri
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Kansas City, Missouri, United States, 64411
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Saint Louis, Missouri, United States, 63110
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New York
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Great Neck, New York, United States, 11021
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Rhode Island
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Providence, Rhode Island, United States, 02903
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South Carolina
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Orangeburg, South Carolina, United States, 29118
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Sumter, South Carolina, United States, 29150
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Tennessee
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Chattanooga, Tennessee, United States, 37408
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Texas
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San Antonio, Texas, United States, 78229
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San Antonio, Texas, United States, 78215
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Utah
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Saint George, Utah, United States, 84770
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Sodium Zirconium Cyclosilicate
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Acute Phase Dosing: Sodium Zirconium Cyclosilicate 10 g three times daily (TID) for 24 to 72 Extended Dosing: Sodium Zirconium Cyclosilicate 5 g once daily (QD).
Sodium Zirconium Cyclosilicate dose increased or decreased in increments/decrements of 5 g QD up to a maximum of 15 g QD or a minimum of 5 g every other day (QOD) based on i-STAT potassium measurements up to 12 months.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percent of Participants With Restoration of Normal Serum Potassium (S-K) Values (3.5 to 5.0 mmol/L, Inclusive) at the End of the Acute Phase
Time Frame: 72 Hours
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Percentage of subjects with S-K values between 3.5 and 5.0 mmol/L, inclusive at the end of the Acute Phase - ITT Population
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72 Hours
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Percentage of Participants With Mean S-K Values ≤ 5.1 mmol/L During Extended Dosing Phase Days 85 to 365
Time Frame: Study Days 85 to 365
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Percentage of subjects with mean S-K values ≤ 5.1 mmol/L during Extended Dosing Phase - ITT Population
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Study Days 85 to 365
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Proportion of Subjects With Mean S-K Between 3.5 and 5.5 mmol/L, Inclusive Months 3 to 12
Time Frame: Study Days 85 to 365
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Proportion of Subjects with mean S-K between 3.5 and 5.5 mmol/L during Extended Dosing Phase - ITT Population
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Study Days 85 to 365
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Mean S-K Levels Months 3 to 12, Months 6 to 9, and Months 9 to 12.
Time Frame: Study days 85 to 365
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Mean S-K levels months 3 to 12(EP Days 85, 113, 141, 176, 211, 239, 267, 295, 330, 365 and EOS),months 6 to 9, and months 9 to 12.
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Study days 85 to 365
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZS-005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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