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
Study 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
Primary Completion Date: 15 Jul 2024
Study Completion Date: 15 Jul 2024
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Jul 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Open-label run-in phase Cohort 1 (4 weeks duration): Patients who are hyperkalemic at study entry will begin SZC 10 g TID for up to 48 hours followed by SZC 10 g once daily to achieve and maintain normokalemia. The SZC dose will be adjusted as needed to maintain normokalemia (dose range = 5 g every other day, to 5-15 g once daily). Cohort 2 (up to 6 weeks duration): Patients who develop hyperkalemia during the uptitration of spironolactone will receive SZC 10 g TID for up to 48 hours followed by SZC 10 g once daily to achieve and maintain normokalemia. The SZC dose will be adjusted as needed to maintain normokalemia (dose range = 5 g every other day, to 5-15 g once daily). | Drug: Sodium zirconium cyclosilicate Investigational medicinal product Other Name: SZC Drug: Placebo Placebo comparator Other Name: placebo Other: Spironolactone Background intervention. During the run-in phase, spironolactone will be initiated/uptitrated up to a maximum of 50 mg per day. During the randomized withdrawal phase the spironolactone dose at the end of the run-in phase will be maintained. Other Name: Spironolactone |
| Experimental: Randomized withdrawal phase (6 months) SZC arm and Placebo arm: Patients will continue on the SZC dose they were receiving at the end of the run-in phase. The SZC / Placebo dose will be adjusted as needed to maintain normokalemia (dose range = 5 g every other day, to 5-15 g once daily). | Drug: Sodium zirconium cyclosilicate Investigational medicinal product Other Name: SZC Drug: Placebo Placebo comparator Other Name: placebo Other: Spironolactone Background intervention. During the run-in phase, spironolactone will be initiated/uptitrated up to a maximum of 50 mg per day. During the randomized withdrawal phase the spironolactone dose at the end of the run-in phase will be maintained. Other Name: Spironolactone |
