Study in Patients With Hyperkalemia-HARMONIZE Asia

Phase 3

• Conditions: Health Condition 1: E875- Hyperkalemia

• Registration Number: CTRI/2019/07/020166
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Applicable
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Optional Pre-screening part of the study

For inclusion in the study patients should fulfill the following 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.

Main part of the study

Above inclusion criteria 2 is also applied to the Main part of the study. In addition, for

inclusion in the study patients should fulfill the following criteria:

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 48-

hour 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 (an acceptable method of contraception is defined as a barrier method in conjunction with a spermicide) 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

7. Patient must have at least one of the following risk factors for Hyperkalemia

(a) Chronic Kidney Disease

(b) Heart Failure

(c) Diabetes Mellitus

8. Documented evidence of at least 2 episodes of hyperkalemia with serum potassium level of >= 5.1 mmol/l at least one week apart within 6 months prior to informed consent.

Exclusion Criteria

Optional Pre-screening part of the study

1.Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)

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

Main part of the study

Above exclusion criteria are also applied to the Main part of the study. In addition, patients should not enter the study if any of the following exclusion criteria are fulfilled:

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 (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

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 subjectsâ?? 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.Patients on dialysis

14.Patients who are blood donors should not donate blood during the study and for 3months following their last dose of ZS

15.Patients who need hospitalization after taking blood samples on day 1 of the 48- hour open-label initial phase

Study & Design

• Study Type: Interventional
• Study Design: Not specified