HARMONIZE Global

Phase 3

• Conditions: Hyperkalemia

• Registration Number: JPRN-jRCT2080223490
• Lead Sponsor: AstraZeneca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-24
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Provision of informed consent prior to any study specific procedures

- Two consecutive i-STAT potassium values, measured 60-minutes apart, both 5.1 mmol/l or more 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

- Involvement in the planning and/or conduct of the study

- 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified