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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Hyperkalaemia, Metabolic Acidosis, Chronic Kidney Disease

In brief

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

Key facts

Study ID

NCT04727528

Run by

AstraZeneca

People needed

39

Starts

2021-03-22

Expected to finish

2022-09-14

Last updated by the study team

2023-10-06

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 16-20 mmol/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 local regulations regarding the methods of contraception for those participating in clinical studies.
• Capable of giving signed informed consent

You may not qualify if…

• Participants with pseudohyperkalemia.
• Dialysis requirement or anticipated by the investigator to require dialysis therapy within 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 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.
• Severe constipation, bowel obstruction or impaction, including abnormal post-operative bowel motility 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

Where it is running

• Research Site — Florence, Alabama, United States
• Research Site — Chula Vista, California, United States
• Research Site — Downey, California, United States
• Research Site — El Centro, California, United States
• Research Site — South Gate, California, United States
• Research Site — Victorville, California, United States
• Research Site — Aurora, Colorado, United States
• Research Site — Denver, Colorado, United States
• Research Site — Coral Gables, Florida, United States
• Research Site — Columbus, Georgia, United States
• Research Site — Hinsdale, Illinois, United States
• Research Site — Kansas City, Missouri, United States
• Research Site — Las Vegas, Nevada, United States
• Research Site — The Bronx, New York, United States
• Research Site — Asheville, North Carolina, United States
• Research Site — New Bern, North Carolina, United States
• Research Site — Winston-Salem, North Carolina, United States
• Research Site — Providence, Rhode Island, United States
• Research Site — Spartanburg, South Carolina, United States
• Research Site — Chattanooga, Tennessee, United States
• Research Site — Memphis, Tennessee, United States
• Research Site — Dallas, Texas, United States
• Research Site — Dallas, Texas, United States
• Research Site — San Antonio, Texas, United States
• Research Site — Shenandoah, Texas, United States

Full record on ClinicalTrials.gov

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