Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes)

  • STATUS
    Recruiting
  • End date
    Mar 22, 2024
  • participants needed
    2300
  • sponsor
    AstraZeneca
Updated on 1 September 2021
Investigator
AstraZeneca Clinical Study Information Center
Primary Contact
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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.

Description

This is an international, multicenter, event-driven, randomized, double-blind, parallel group, placebo-controlled study, evaluating the utility of SZC versus placebo to reduce the incidence of sudden cardiac death (SCD), stroke, and arrhythmia-related hospitalizations, interventions, and emergency department (ED) visits in participants on chronic hemodialysis with recurrent hyperkalemia.

Details
Condition Hyperkalemia
Treatment Sodium Zirconium Cyclosilicate (SZC), SZC Placebo
Clinical Study IdentifierNCT04847232
SponsorAstraZeneca
Last Modified on1 September 2021

Eligibility

Yes No Not Sure

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. For participants < 20 years of age and enrolled in Japan, a written informed consent should be obtained from the participant and his or her legally acceptable representative
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)
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
Symptomatic or uncontrolled AF despite treatment, or asymptomatic sustained ventricular tachycardia
Treated with SPS (eg, Kayexalate, Resonium), CPS (Resonium Calcium), patiromer (Veltassa), or SZC (Lokelma) within 7 days before screening
Participation in another clinical study with an investigational product administered within one month before screening
Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements
Previous randomization in the present study
Females who are pregnant (confirmed with positive pregnancy test or a uterine ultrasound if pregnancy test result is questionable), breastfeeding, or planning to become pregnant during the study
Known hypersensitivity or previous anaphylaxis to SZC or to components thereof
Scheduled date for living donor kidney transplant
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