A Study to Investigate the Safety and Efficacy of ZS in Patients With Hyperkalemia.
NCT ID: NCT03528681
Last Updated: 2025-05-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
270 participants
INTERVENTIONAL
2021-05-06
2022-09-15
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 10g
Suspension administered 10g orally once daily for 28 days after the open label initial phase.
Sodium Zirconium Cyclosilicate 10g
Suspension administered Sodium Zirconium Cyclosilicate 10g orally once daily for 28 days after the open label initial phase with suspension administered Sodium Zirconium Cyclosilicate 10g orally three times per day for at most 2 days.
Sodium Zirconium Cyclosilicate 5g
Suspension administered 5g orally once daily for 28 days after the open label initial phase.
Sodium Zirconium Cyclosilicate 5g
Suspension administered Sodium Zirconium Cyclosilicate 5g orally once daily for 28 days after the open label initial phase with suspension administered Sodium Zirconium Cyclosilicate 10g orally three times per day for at most 2 days.
Matching Placebo
Suspension administered orally placebo once daily for 28 days after the open label initial phase.
Placebo
Suspension administered orally placebo once daily for 28 days after the open label initial phase with suspension administered Sodium Zirconium Cyclosilicate 10g orally three times per day for at most 2 days.
Interventions
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Sodium Zirconium Cyclosilicate 5g
Suspension administered Sodium Zirconium Cyclosilicate 5g orally once daily for 28 days after the open label initial phase with suspension administered Sodium Zirconium Cyclosilicate 10g orally three times per day for at most 2 days.
Sodium Zirconium Cyclosilicate 10g
Suspension administered Sodium Zirconium Cyclosilicate 10g orally once daily for 28 days after the open label initial phase with suspension administered Sodium Zirconium Cyclosilicate 10g orally three times per day for at most 2 days.
Placebo
Suspension administered orally placebo once daily for 28 days after the open label initial phase with suspension administered Sodium Zirconium Cyclosilicate 10g orally three times per day for at most 2 days.
Eligibility Criteria
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Inclusion Criteria
2. Female and male patients aged ≥18 and ≤ 90 years
3. Provision of informed consent prior to any study specific procedures
4. 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 open-label initial phase Day 1
5. Ability to have repeated blood draws or effective venous catheterization
6. Female patients must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception for the duration of the study (from the time they sign consent) and for 3 months after the last dose of ZS/matching placebo to prevent pregnancy. In addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used
Exclusion Criteria
2. Participation in another clinical study with an investigational product during the last 3 months
3. 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
4. Pseudohyperkalemia signs and symptoms, such as hemolyzed blood specimen due to excessive fist clenching to make veins prominent, difficult or traumatic venepuncture, or history of severe leukocytosis or thrombocytosis
5. Patients treated with lactulose, xifaxan (rifaximin) or other non-absorbed antibiotics for hyperammonemia within 7 days prior to the first dose of study drug
6. Patients treated with resins,calcium acetate,calcium carbonate, or lanthanum carbonate,within 7 days prior to the first dose of study drug
7. Patients with a life expectancy of less than 3 months
8. 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
9. Female patients who are pregnant, lactating, or planning to become pregnant
10. Patients with diabetic ketoacidosis
11. Known hypersensitivity or previous anaphylaxis to ZS or to components thereof
12. Patients with cardiac arrhythmias that require immediate treatment
13. History of QT prolongation associated with other medications that required discontinuation of that medication.
14. Congenital long QT syndrome
15. Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted
16. QTc(f) \> 550 msec
17. Patients on dialysis
18. Patients who are blood donors should not donate blood during the study and for 3 months following their last dose of ZS
19. Patients who need hospitalization after taking blood samples on day 1 of the open-label initial phase
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
Baotou, , China
Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Bengbu, , China
Research Site
Changchun, , China
Research Site
Changsha, , China
Research Site
Changsha, , China
Research Site
Chengdu, , China
Research Site
Chengdu, , China
Research Site
Dalian, , China
Research Site
Dongguan, , China
Research Site
Fuzhou, , China
Research Site
Fuzhou, , China
Research Site
Guangzhou, , China
Research Site
Guangzhou, , China
Research Site
Guiyang, , China
Research Site
Haikou, , China
Research Site
Hangzhou, , China
Research Site
Hangzhou, , China
Research Site
Hefei, , China
Research Site
Hefei, , China
Research Site
Jilin, , China
Research Site
Jinan, , China
Research Site
Jingzhou, , China
Research Site
Kunming, , China
Research Site
Kunming, , China
Research Site
Lanzhou, , China
Research Site
Nanchang, , China
Research Site
Ningbo, , China
Research Site
Qingdao, , China
Research Site
Shanghai, , China
Research Site
Shanghai, , China
Research Site
Shanghai, , China
Research Site
Suzhou, , China
Research Site
Taiyuan, , China
Research Site
Taiyuan, , China
Research Site
Tianjin, , China
Research Site
Tianjin, , China
Research Site
Wuhan, , China
Research Site
Wuhan, , China
Research Site
Wuxi, , China
Research Site
Xi'an, , China
Research Site
Xiamen, , China
Research Site
Xining, , China
Research Site
Xining, , China
Research Site
Yangzhou, , China
Research Site
Yichang, , China
Research Site
Yinchuan, , China
Research Site
Zhanjiang, , China
Research Site
Zhuzhou, , China
Research Site
Ahmedabad, , India
Research Site
Ahmedabad, , India
Research Site
Ahmedabad, , India
Research Site
Bangalore, , India
Research Site
Bangalore, , India
Research Site
Bengaluru, , India
Research Site
Chandigarh, , India
Research Site
Chennai, , India
Research Site
Hyderabad, , India
Research Site
Kolkata, , India
Research Site
Nagpur, , India
Research Site
New Delhi, , India
Research Site
New Delhi, , India
Research Site
Vijayawada, , India
Countries
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References
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Liang X, Lu W, Yu X, Cheng H, He Q, Peng Q, Ni Z, Long G, Wang L, Chen W, Li R, Zhao J, Zhang Y, Lisovskaja V, Tang Z. HARMONIZE Asia: A Phase III Randomized Study to Investigate the Efficacy and Safety of Sodium Zirconium Cyclosilicate in Patients with Hyperkalemia in China. Clin Ther. 2024 Sep;46(9):702-710. doi: 10.1016/j.clinthera.2024.07.004. Epub 2024 Aug 6.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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D9480C00001
Identifier Type: -
Identifier Source: org_study_id
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