A Phase IV, Multicentre, Non-comparative, Open-label Study Evaluating the Safety and Effectiveness of Lokelma - LOHKALT

Inclusion Criteria

• Inclusion Criteria:
• - • Participant must be ≥ 18 years of age, at the time of signing the informed consent.
• • Participants with mild to moderate hyperkalaemia- the potassium values between 5.1 to 6.4 mmol/L inclusive, at screening (Day 0)
• • Ability to have repeated blood draws or effective venous catheterisation.
• • Contraceptive use by females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. i) FOCBP must be using two forms of medically acceptable contraception (at least one barrier method) and have a negative pregnancy test at screening. The female participants should be on stable on their chosen method of birth control for minimum of one month before entering the study and willing to remain on the birth control until 7 days after the last dose. ii) Female participants who are surgically sterile or those who are post-menopausal (if they have been amenorrhoeic for 12 months prior to the planned date of screening without an alternative medical cause) are not considered to be of child-bearing potential.
• • Capable of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
• Exclusion Criteria:
• -• As judged by the investigator, any evidence of oedema which in the investigator’s
• opinion makes it undesirable for the participant to participate in the study.
• • Patients undergoing haemodialysis or a prospective candidate for haemodialysis.
• • Pseudo hyperkalaemia signs and symptoms, such as excessive fist clenching haemolysed blood specimen, severe leucocytosis or thrombocytosis.
• • Participants with a life expectancy of < 12 months.
• • Participants who are severely physically or mentally incapacitated and who in the opinion of investigator are unable to perform the participants' tasks associated with the protocol.
• • Women who are pregnant, lactating, or planning to become pregnant.
• • Participants with diabetic ketoacidosis.
• • Presence of any condition which, in the opinion of the investigator, places the participant at undue risk.
• • Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia.
• • Participants with cardiac arrhythmias requiring immediate treatment.
• • Participants with history of QT prolongation associated with other medications that required discontinuation of that medication.
• • Participants with congenital long QT syndrome.
• • Participants treated with lactulose, rifaximin or other non-absorbed antibiotics for hyperammonaemia within the last 7 days.
• • Participants treated with resins (such as sevelamer acetate), calcium acetate, calcium carbonate, or lanthanum carbonate, within the last 7 days.
• • Participants treated with SPS or SZC (microporous, fractionated, protonated zirconium silicate), CPS or patiromer within the last 7 days.
• • Known hypersensitivity or previous anaphylaxis to SZC or to components or any of the excipients of the product.
• • Treatment with a drug or device within the last 30 days that has not received regulatory approval at the time of study entry.
• • Prior (within last 1 month) and ongoing participation in another clinical trial,
• observational study, and real-world evidence study.
• • Positive hepatitis C antibody, hepatitis B virus surface antigen, or hepatitis B virus core antibody, at screening.
• • Known to have tested positive for HIV.
• • Documented glomerular filtration rate < 15 mL/min/1.73 m2 within 90 days before study entry.
• • Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
• • Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.