Study of the Effect of SZC on Serum Potassium and Serum Bicarbonate in Patients With Hyperkalemia and Metabolic Acidosis Associated With Chronic Kidney Disease

Inclusion Criteria:

• Adults aged ≥18 years
• Participants who have CKD stage 3-5, not on dialysis.
• POCT K+ level >5 mmol/L to ≤5.9 mmol/L and POCT bicarbonate levels between 16-20mmol/L inclusive prior to the first SZC dose on study Day 1
• Ability to have repeated blood draws or effective venous catheterization.
• Male and/or female. Contraceptive use by men or women should be consistent with localregulations regarding the methods of contraception for those participating in clinicalstudies.
• Capable of giving signed informed consent

Exclusion Criteria:

• Participants with pseudohyperkalemia.
• Dialysis requirement or anticipated by the investigator to require dialysis therapywithin 1 month, history of renal transplant, or life expectancy less than 3 months.
• Cardiac arrhythmias requiring immediate treatment.
• Active or suspected diabetic ketoacidosis.
• POCT bicarbonate low enough to need emergency intervention or treatment as judged bythe investigator.
• Acute/chronic worsening renal function (eg, ≥30% decline in eGFR) in the 3 monthsbefore screening.
• Current acute decompensated HF, hospitalization due to decompensated HF within 4 weeksprior to screening, or myocardial infarction (MI), unstable angina, stroke ortransient ischemic attack (TIA) within 12 weeks prior to screening.
• Coronary revascularization (percutaneous coronary intervention [PCI] or coronaryartery bypass grafting [CABG]) or valvular repair/replacement within 12 weeks prior toscreening or planned to undergo any of these operations.
• Symptomatic hypotension.
• Current exacerbation of chronic obstructive pulmonary disease (COPD)/asthma orhospitalization due to exacerbation of COPD/asthma within 4 weeks of screening.
• Severe constipation, bowel obstruction or impaction, including abnormal post-operativebowel motility disorders
• Active malignancy requiring treatment.
• History of QT prolongation associated with other medications that requireddiscontinuation of that medication.
• Congenital long QT syndrome.
• Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomaticsustained ventricular tachycardia. Patients with atrial fibrillation controlled bymedication are permitted.
• QTcF (QT interval corrected by the Fridericia method) >550 msec.
• Active treatment (within 7 days prior to screening) with SZC, sodium bicarbonate,sodium polystyrene sulfonate, lactulose, or patiromer