A Study to Investigate the Safety and Efficacy of ZS in Patients With Hyperkalemia
NCT ID: NCT02875834
Last Updated: 2020-08-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
267 participants
INTERVENTIONAL
2017-03-03
2018-02-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Sodium Zirconium Cyclosilicate (ZS) 5g
Suspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase.
Sodium Zirconium Cyclosilicate (ZS) 5g
Suspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase.
Sodium Zirconium Cyclosilicate (ZS) 10g
Suspension administered 10g orally once daily for 28 days after the first 48-hour open label initial phase.
Sodium Zirconium Cyclosilicate (ZS) 10g
Suspension administered 10g orally three times per day, in the first 48-hour of the study for all patients (48-hour open label initial phase)
Sodium Zirconium Cyclosilicate (ZS) 10g
Suspension administered 10g orally once daily for 28 days after the first 48-hour open label initial phase.
Placebo
Suspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase.
Placebo
Suspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase.
Interventions
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Sodium Zirconium Cyclosilicate (ZS) 10g
Suspension administered 10g orally three times per day, in the first 48-hour of the study for all patients (48-hour open label initial phase)
Sodium Zirconium Cyclosilicate (ZS) 5g
Suspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase.
Sodium Zirconium Cyclosilicate (ZS) 10g
Suspension administered 10g orally once daily for 28 days after the first 48-hour open label initial phase.
Placebo
Suspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase.
Eligibility Criteria
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Inclusion Criteria
* Female and male patients aged ≥18 and ≤ 90 years
* Two consecutive i-STAT potassium values, measured 60-minutes (± 10 minutes) apart, both ≥ 5.1 mmol/l and measured within 1 day of the first ZS dose on 48-hour open-label initial phase Day 1
* Ability to have repeated blood draws or effective venous catheterization
* Female patients must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception for the duration of the study and for 3 months after the last dose of ZS/matching placebo to prevent pregnancy.
Exclusion Criteria
* Participation in another clinical study with an investigational product during the last 3 months
* Pseudohyperkalemia signs and symptoms
* Patients treated with lactulose, xifaxan (rifaximin) or other non-absorbed antibiotics for hyperammonemia within 7 days prior to the first dose of study drug
* Patients treated with resins,calcium acetate,calcium carbonate, or lanthanum carbonate,within 7 days prior to the first dose of study drug
* Patients with a life expectancy of less than 3 months
* Patients 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
* Female patients who are pregnant, lactating, or planning to become pregnant
* Patients with diabetic ketoacidosis
* Presence of any condition which, in the opinion of the investigator, places the patient 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
* Patients with cardiac arrhythmias that require immediate treatment
* Patients on dialysis
* Patients who are blood donors should not donate blood during the study and for 3 months following their last dose of ZS
18 Years
90 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Chiba, , Japan
Research Site
Hanyu-shi, , Japan
Research Site
Hitachi-Naka, , Japan
Research Site
Ina-shi, , Japan
Research Site
Kanazawa, , Japan
Research Site
Koga-shi, , Japan
Research Site
Matsudo-shi, , Japan
Research Site
Nagoya, , Japan
Research Site
Nagoya, , Japan
Research Site
Shimajiri-gun, , Japan
Research Site
Shizuoka, , Japan
Research Site
Toride-shi, , Japan
Research Site
Toyohashi, , Japan
Research Site
Yakushi, , Japan
Research Site
Krasnoyarsk, , Russia
Research Site
Moscow, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Yaroslavl, , Russia
Research Site
Yekaterinburg, , Russia
Research Site
Anyang-si, , South Korea
Research Site
Bucheon-si, , South Korea
Research Site
Bucheon-si, , South Korea
Research Site
Busan, , South Korea
Research Site
Cheongju-si, , South Korea
Research Site
Goyang-si, , South Korea
Research Site
Goyang-si, , South Korea
Research Site
Gwangju, , South Korea
Research Site
Hwaseong-si, , South Korea
Research Site
Incheon, , South Korea
Research Site
Incheon, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Suwon, , South Korea
Research Site
Uijeongbu-si, , South Korea
Research Site
Wŏnju, , South Korea
Research Site
Hualien City, , Taiwan
Research Site
New Taipei City, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taipei, , Taiwan
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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Other Identifiers
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D9480C00002
Identifier Type: -
Identifier Source: org_study_id
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