Study to assess efficacy and safety of SZC for the Management of High Potassium in Patients with Symptomatic HFrEF Receiving Spironolactone - REALIZE-K

Study identifier:D9480C00018

ClinicalTrials.gov identifier:NCT04676646

EudraCT identifier:2020-003312-27

CTIS identifier:N/A

Recruitment Complete

Official Title

Phase IV, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Trial Evaluating Sodium Zirconium Cyclosilicate (SZC) for the Management of Hyperkalaemia in Patients with Symptomatic Heart Failure with Reduced Ejection Fraction and Receiving Spironolactone

Medical condition

Hyperkalaemia

Phase

Phase 4

Healthy volunteers

No

Study drug

Sodium zirconium cyclosilicate, Placebo

Sex

All

Actual Enrollment

366

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 08 Mar 2021
Estimated Primary Completion Date: 31 Jul 2024
Estimated Study Completion Date: 31 Jul 2024

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Feb 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria