Study of the Effect of SZC on Serum Potassium and Serum Bicarbonate in Patients With Hyperkalemia and Metabolic Acidosis Associated With Chronic Kidney Disease
NCT ID: NCT04727528
Last Updated: 2023-10-06
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
39 participants
INTERVENTIONAL
2021-03-22
2022-09-14
Brief Summary
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Detailed Description
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The study will be conducted in the United States (US) at approximately 35 investigative sites.
After screening on Day 1, all eligible patients will receive open-label SZC for up to 48 hours. Patients who achieve normokalemia within 48 hours will be randomized 1:1 into the double-blind randomized treatment phase to receive SZC or placebo. Study treatment will end with the Day 29 visit, which will be followed by a follow-up visit 7 days after the last administration of study medication.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Open-label correction phase (up to 48 hours)
All eligible patients will receive SZC 10 g TID for up to 48 hours. Patients with POCT (Point-of-Care-Test) K+ ≥5.1 mmol/L after 24 hours will continue on SZC 10 g TID for another 24 hours. Patients who achieve normokalemia (defined as POCT K+ between 3.5 and 5.0 mmol/L inclusive) after receiving SZC 10 g TID for up to 48 hours will proceed to randomization.
Patients with POCT K+ \<3.5mmol/L at any time during the open-label phase will be withdrawn from study treatment and will be followed per protocol.
Sodium zirconium cyclosilicate
Investigational medicinal product
Placebo
Plabeco comparator
Randomized, placebo controlled phase (Day 2 or 3 to Day 29)
Patients will be randomized to SZC 10 g QD or placebo 10 g QD. The dose of SZC/placebo will be titrated by increasing or decreasing the dose by 5 g increments at 1-week intervals to between 5 g every other day (QOD) and 15 g QD of the randomized phase to maintain normokalemia by POCT K+.
Sodium zirconium cyclosilicate
Investigational medicinal product
Placebo
Plabeco comparator
Interventions
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Sodium zirconium cyclosilicate
Investigational medicinal product
Placebo
Plabeco comparator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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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
Research Site
Alexandria, Virginia, United States
Research Site
Norfolk, Virginia, United States
Research Site
Bellevue, Washington, United States
Research Site
Milwaukee, Wisconsin, United States
Research Site
San Juan, , Puerto Rico
Countries
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References
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Ash SR, Batlle D, Kendrick J, Oluwatosin Y, Kooienga L, Eudicone JM, Sundin AK, Guerrieri E, Fried LF. Sodium Zirconium Cyclosilicate in CKD, Hyperkalemia, and Metabolic Acidosis: NEUTRALIZE Randomized Study. Kidney360. 2024 Jun 1;5(6):812-820. doi: 10.34067/KID.0000000000000446. Epub 2024 Apr 16.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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D9480C00022
Identifier Type: -
Identifier Source: org_study_id
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