A Study to Investigate the Safety and Efficacy of ZS in Patients With Hyperkalemia.

• Status: Recruiting
• Trial end date: 2022-06-13
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy of two different doses (5 and 10 g) of ZS orally administered once daily (qd) vs placebo in maintaining normokalemia in initially hyperkalemic patients having achieved normokalemia following 24 or 48 hours of initial ZS therapy (10g TID).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca

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