A study to investigate the safety and efficacy of ZS in patients with hyperkalemia. - HARMONIZE Asia

Study identifier:D9480C00001

ClinicalTrials.gov identifier:NCT03528681

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A phase 3 multicenter, prospective, randomized, double-blind, placebo-controlled study to investigate the safety and efficacy of ZS (sodium zirconium cyclosilicate), in patients with hyperkalemia-HARMONIZE Asia

Medical condition

Hyperkalemia

Phase

Phase 3

Healthy volunteers

Study drug

Sodium Zirconium Cyclosilicate 5g, Sodium Zirconium Cyclosilicate 10g, Placebo

Sex

All

Actual Enrollment

250

Study type

Interventional

Age

18 Years - 90 Years

Date

Study Start Date: 06 May 2021

Primary Completion Date: 15 Sept 2022

Study Completion Date: 15 Sept 2022

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2023 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

1. Provision of informed consent (pre-screening consent) prior to any study specific procedures
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

1. Involvement in the planning and/or conduct of the study
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

No locations available

Arms	Assigned Interventions
Experimental: Sodium Zirconium Cyclosilicate 10g Suspension administered 10g orally once daily for 28 days after the open label initial phase.	Drug: 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.
Experimental: Sodium Zirconium Cyclosilicate 5g Suspension administered 5g orally once daily for 28 days after the open label initial phase.	Drug: 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.
Placebo Comparator: Matching Placebo Suspension administered orally placebo once daily for 28 days after the open label initial phase.	Drug: 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.

Documents available

CSP Redacted
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SAP Redacted
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CSR Synopsis Redacted
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Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]