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

• Status: Recruiting
• Trial end date: 2022-02-24
• Target enrollment: 0
• Participant gender: All

Summary

The main objective of this study is to evaluate the efficacy of SZC as compared to placebo in maintaining normal sK+ in patients with hyperkalemia and metabolic acidosis associated with CKD

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

Details

• Lead Sponsor: AstraZeneca

Criteria

Inclusion Criteria:

• Adults aged ≥18 years

• Participants who have CKD stage 3-5, not on dialysis.

• Two consecutive POCT K+ levels >5 mmol/L to ≤5.9 mmol/L and POCT bicarbonate levels between 16-20 mmol/L inclusive on 2 measurements 60 minutes apart (±15 minutes) 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 local regulations regarding the methods of contraception for those participating in clinical studies.

• Capable of giving signed informed consent

Exclusion Criteria:

• Participants with pseudohyperkalemia.

• Dialysis requirement or anticipated by the investigator to require dialysis therapy within 3 months, 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 by the investigator.

• Acute/chronic worsening renal function (eg, ≥30% decline in eGFR) in the 3 months before screening.

• Current acute decompensated HF, hospitalization due to decompensated HF within 4 weeks prior to screening, or myocardial infarction (MI), unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to screening.

• Coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) or valvular repair/replacement within 12 weeks prior to screening or planned to undergo any of these operations.

• Symptomatic hypotension.

• Current exacerbation of chronic obstructive pulmonary disease (COPD)/asthma or hospitalization due to exacerbation of COPD/asthma within 4 weeks of screening.

• History of diabetic gastroparesis, bariatric surgery, bowel obstruction, swallowing disorders.

• Active malignancy requiring treatment.

• History of QT prolongation associated with other medications that required discontinuation of that medication.

• Congenital long QT syndrome.

• Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Patients with atrial fibrillation controlled by medication 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