Safety & Efficacy of Zirconium Silicate Dosed for 28 Days in Hyperkalemia.
NCT ID: NCT02088073
Last Updated: 2018-12-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
258 participants
INTERVENTIONAL
2014-03-31
2015-01-31
Brief Summary
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Detailed Description
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Initially all subjects will receive open-label ZS at a dose of 10g three times a day (tid) for 48 hours (AP). Subjects who achieve normokalemia (i-STAT potassium values between 3.5 to 5.0 mmol/l, inclusive) on the morning of Study Day 3 (after 6 doses of 10g ZS) will then, in a double-blind fashion, be randomized 4:4:4:7 to receive one of three doses of ZS (5g, 10g or 15g) or placebo control, qd for the following 28 days (DBRMP).
Safety and tolerability will be assessed on an ongoing basis by an Independent Data Monitoring Committee (iDMC). Each active dose group in the DBRMP will consist of 49 subjects and the placebo control group will consist of 85 subjects for a total of 232 subjects to detect a 0.6 effect size difference between each ZS dose (from highest to lowest) and placebo control; the 4:4:4:7 allocation optimizes the multiple comparisons to the placebo control for the DBRMP.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Sodium zirconium cyclosilicate 10 g three times daily
Sodium zirconium cyclosilicate 10 g three times daily for 48 hours (acute phase)
Sodium zirconium cyclosilicate
Sodium zirconium cyclosilicate
Placebo once daily
Randomized to mimic doses of experimental drug administered once daily with breakfast for 28 days.
Placebo
Randomized to mimic doses of experimental drug administered once daily with breakfast for 28 days (maintenance phase)
Sodium zirconium cyclosilicate 5 g once daily
Sodium zirconium cyclosilicate (ZS) 5 g once daily for 28 days (maintenance phase)
Sodium zirconium cyclosilicate
Sodium zirconium cyclosilicate
Sodium zirconium cyclosilicate 10 g once daily
Sodium zirconium cyclosilicate (ZS) 10 g once daily for 28 days (maintenance phase)
Sodium zirconium cyclosilicate
Sodium zirconium cyclosilicate
Sodium zirconium cyclosilicate 15 g once daily
Sodium zirconium cyclosilicate (ZS) 15 g once daily for 28 days (maintenance phase)
Sodium zirconium cyclosilicate
Sodium zirconium cyclosilicate
Interventions
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Sodium zirconium cyclosilicate
Sodium zirconium cyclosilicate
Placebo
Randomized to mimic doses of experimental drug administered once daily with breakfast for 28 days (maintenance phase)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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ZS Pharma, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Henrik Rasmussen, MD, PhD
Role: STUDY_CHAIR
ZS Pharma, Inc.
Locations
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Anniston, Alabama, United States
Huntsville, Alabama, United States
Scottsboro, Alabama, United States
Phoenix, Arizona, United States
Tempe, Arizona, United States
Hawaiian Gardens, California, United States
Los Angeles, California, United States
Paramount, California, United States
Riverside, California, United States
Atlantis, Florida, United States
Bradenton, Florida, United States
Brandon, Florida, United States
Brooksville, Florida, United States
DeLand, Florida, United States
Edgewater, Florida, United States
Miami, Florida, United States
Miami Lakes, Florida, United States
New Smyrna Beach, Florida, United States
Ocala, Florida, United States
Summerfield, Florida, United States
Tampa, Florida, United States
Winter Park, Florida, United States
Columbus, Georgia, United States
Decatur, Georgia, United States
Evergreen Park, Illinois, United States
Joliet, Illinois, United States
Shreveport, Louisiana, United States
Auburn, Maine, United States
Chesterfield, Michigan, United States
Kansas City, Missouri, United States
Las Vegas, Nevada, United States
Flushing, New York, United States
Altoona, Pennsylvania, United States
Providence, Rhode Island, United States
Orangeburg, South Carolina, United States
Sumter, South Carolina, United States
Chattanooga, Tennessee, United States
San Antonio, Texas, United States
Gosford, New South Wales, Australia
Woolloongabba, Queensland, Australia
Heidelberg, Victoria, Australia
Melbourne, Victoria, Australia
Parkville, Victoria, Australia
Meyerspark, , South Africa
Port Elizabeth, , South Africa
Somerset West, , South Africa
Countries
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References
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Natale P, Palmer SC, Ruospo M, Saglimbene VM, Strippoli GF. Potassium binders for chronic hyperkalaemia in people with chronic kidney disease. Cochrane Database Syst Rev. 2020 Jun 26;6(6):CD013165. doi: 10.1002/14651858.CD013165.pub2.
Amin AN, Menoyo J, Singh B, Kim CS. Efficacy and safety of sodium zirconium cyclosilicate in patients with baseline serum potassium level >/= 5.5 mmol/L: pooled analysis from two phase 3 trials. BMC Nephrol. 2019 Dec 2;20(1):440. doi: 10.1186/s12882-019-1611-8.
Kosiborod M, Rasmussen HS, Lavin P, Qunibi WY, Spinowitz B, Packham D, Roger SD, Yang A, Lerma E, Singh B. Effect of sodium zirconium cyclosilicate on potassium lowering for 28 days among outpatients with hyperkalemia: the HARMONIZE randomized clinical trial. JAMA. 2014 Dec 3;312(21):2223-33. doi: 10.1001/jama.2014.15688.
Other Identifiers
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ZS-004
Identifier Type: -
Identifier Source: org_study_id