SZC for High Potassium in Heart Failure Patients (REALIZE-K Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Prior Safety Data

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?This trial tests if SZC can keep potassium levels normal in heart failure patients taking spironolactone. SZC acts like a sponge to soak up extra potassium and remove it from the body. SZC is a newly introduced treatment that effectively lowers and maintains normal potassium levels in patients with high potassium.

Eligibility Criteria

Adults over 18 with heart failure and high potassium levels, taking specific heart medications, can join this trial. They must have a stable blood pressure and not be hospitalized for unstable heart conditions or on certain intravenous drugs.

Inclusion Criteria

I am taking medication for my blood pressure or heart condition.

My blood potassium is between 5.1-5.9 and my kidney function is good.

My potassium levels are between 4.5 and 5.0, and I am over 75 years old.

My potassium levels are between 4.5-5.0 and my kidney function is moderately reduced.

I am not taking or only taking a low dose of spironolactone or eplerenone.

I have had high potassium levels and my kidney function is okay.

Exclusion Criteria

My heart failure is caused by a specific heart condition.

I am currently hospitalized with unstable heart failure.

Treatment Details

The study tests if SZC keeps potassium levels normal in patients with symptomatic HFrEF who are also taking spironolactone. Participants will either receive SZC or a placebo to compare effectiveness without rescue therapy.

2Treatment groups

Experimental Treatment

Group I: Randomized withdrawal phase (6 months)Experimental Treatment3 Interventions

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).

Group II: Open-label run-in phaseExperimental Treatment3 Interventions

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).

Sodium zirconium cyclosilicate is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Lokelma for: