Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Particip… (NCT04847232) | Clinical Trial Compass
TerminatedPhase 3
Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes)
Stopped: The event rate observed in the study continued to be below primary assumptions, so that the completion of the study within a reasonable timeframe was deemed very unlikely.
United States2,690 participantsStarted 2021-04-30
Plain-language summary
The purpose of this study is to evaluate the effect of Sodium Zirconium Cyclosilicate (SZC) on arrhythmia-related cardiovascular outcomes in participants on chronic hemodialysis with recurrent hyperkalemia.
Who can participate
Age range18 Years – 130 Years
SexALL
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Inclusion criteria
✓. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
✓. Provision of signed and dated, written ICF prior to any mandatory study specific procedures, sampling, and analyses
✓. Must be ≥ 18 years of age, at the time of signing the ICF.
✓. Receiving hemodialysis (or hemodiafiltration) 3 times a week for treatment of ESRD for ≥ 4 months before enrollment
✓. Must have hemodialysis access consisting of an arteriovenous fistula, arteriovenous graft, or tunneled (permanent) catheter which is expected to remain in place for the entire duration of the study
✓. At least 2 out of 3 pre-dialysis S K ≥ 5.5 mmol/L after the LIDI during screening
✓. Negative pregnancy test for female participants of childbearing potential
✓. Female participants must be 1 year postmenopausal, surgically sterile, or using one highly effective form of birth control (defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly). They should have been stable on their chosen method of birth control for a minimum of 3 months before entering the study and willing to remain on the birth control until 12 weeks after the last dose
Exclusion criteria
✕. Pseudohyperkalemia secondary to hemolyzed blood specimen (this situation is not considered screening failure, sampling or full screening can be postponed to a later time as applicable)
What they're measuring
1
Incidence of the Composite of Cardiac Event Outcomes
Timeframe: From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)
. Presence of cardiac arrhythmias or conduction defects that require immediate treatment
✕. Participants who have a pacemaker or implantable cardiac defibrillator
✕. Any medical condition, including active, clinically significant infection or liver disease, that in the opinion of the investigator or sponsor may pose a safety risk to a participant in this study, confound safety or efficacy assessment and jeopardize the quality of the data, or interfere with study participation, or any other restrictions or contraindications in the local prescribing information for SZC
✕. History of QT prolongation associated with other medications that required discontinuation of that medication
✕. Congenital long QT syndrome
✕. QTcF \> 550 msec
✕. Atrial fibrillation requiring immediate/urgent intervention at screening or randomizations