NCT04847232

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

An International, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,690 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hyperkalemia

Interventions

Type	Name	Description
DRUG	Sodium Zirconium Cyclosilicate (SZC)	Powder for oral suspension in a sachet. A dose is titrated in 5 g increments during a period of 4 weeks from 5 g up to 15 g qd on non-dialysis days. Afterward, the dose is adjusted monthly (or more frequent based on clinical judgment) depending on the current potassium value as measured after the long interdialytic interval (LIDI).
DRUG	SZC Placebo	Powder for oral suspension in a sachet. A dose is titrated in 5 g increments during a period of 4 weeks from 5 g up to 15 g qd on non-dialysis days. Afterward, the dose is adjusted monthly (or more frequent based on clinical judgment) depending on the current potassium value as measured after the LIDI.

Timeline

• Start date: 2021-04-30
• Primary completion: 2024-03-07
• Completion: 2024-03-07
• First posted: 2021-04-19
• Last updated: 2025-06-18
• Results posted: 2025-06-18

Locations

340 sites across 26 countries: United States, Argentina, Austria, Brazil, Bulgaria, Canada, China, Czechia, Germany, Hungary, India, Italy, Japan, Malaysia, Mexico, Peru, Poland, Russia, Slovakia, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, Vietnam

Regulatory

• FDA-regulated drug study