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Electrolyte Modifying Agent

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

Phase 4

Waitlist Available

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Receiving angiotensin-converting enzyme inhibitor (ACEi), angiotensin II receptor blocker (ARB), or angiotensin receptor-Neprilysin inhibitor (ARNi)

Cohort 1: sK+ 5.1-5.9 mEq/L at screening/study enrolment and eGFR ≥30 mL/min/1.73 m2; OR

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the monthly visits are used for response assessment from month 1 to month 6

Awards & highlights

REALIZE-K Trial Summary

This trial will compare the effectiveness of SZC to a placebo in keeping potassium levels normal while taking spironolactone.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While the side effects of SZC aren't detailed here, common ones may include nausea, vomiting, constipation, and swelling. Spironolactone can cause kidney problems, high potassium levels, dizziness, rash.

REALIZE-K Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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

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

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

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

REALIZE-K Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the monthly visits are used for response assessment from month 1 to month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the monthly visits are used for response assessment from month 1 to month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and the monthly visits are used for response assessment from month 1 to month 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Response is defined by Having(sK+) within 3.5-5.0 mEq/L AND Being on spironolactone ≥25 mg daily AND Not using rescue therapy for HK during the last month. The treatment effect concerns the overall

Secondary outcome measures

Change in KCCQ-CSS at EOT visit (approximately 6 months post-randomisation) from randomisation. SZC compared with placebo using difference in mean

Per visit, response is defined by Having potassium (sK+) within 3.5-5.0 mEq/L as assessed by central laboratory AND Being on the same spironolactone dose as they were at randomisation AND Not using rescue therapy for HK during the last month

Response is defined by Being on spironolactone ≥25 mg daily The treatment effect concerns the overall

+2 more

REALIZE-K Trial Design

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sodium zirconium cyclosilicate

2014

Completed Phase 3

~320

Placebo

1995

Completed Phase 3

~2670

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,257 Previous Clinical Trials

288,593,420 Total Patients Enrolled

84 Trials studying Heart Failure

165,660 Patients Enrolled for Heart Failure

Media Library

Sodium zirconium cyclosilicate (Electrolyte Modifying Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04676646 — Phase 4

Heart Failure Research Study Groups: Randomized withdrawal phase (6 months), Open-label run-in phase

Heart Failure Clinical Trial 2023: Sodium zirconium cyclosilicate Highlights & Side Effects. Trial Name: NCT04676646 — Phase 4

Sodium zirconium cyclosilicate (Electrolyte Modifying Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04676646 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the enrollment figure for this research undertaking?

"Affirmative. According to information listed on clinicaltrials.gov, this research is still searching for participants and was initially published on March 8th 2021. Last updated November 29th 2022, the trial requires 260 people from 26 distinct medical sites."

Answered by AI

What is the goal of this research endeavor?

"This study, which will be assessed over a 6 month period from randomization to the end of treatment visit (EOT), aims to evaluate the efficacy and safety of SZC compared with placebo in maintaining normal potassium levels (3.5-5.0 mEq/L) whilst taking spironolactone ≥25 mg daily without rescue therapy for hyperkalaemia. Secondary objectives include: evaluating time to first HK episode; comparing SZC and placebo arms regarding keeping serum potassium ≤ 5mEq/L; assessing whether or not at EOT patients are on same dose of spironolactone as used"

Answered by AI

Is Sodium zirconium cyclosilicate risk-free for human consumption?

"The safety of sodium zirconium cyclosilicate has been confirmed in a Phase 4 clinical trial, and our team at Power assigns it the highest rating possible: 3."

Answered by AI

Is enrollment open to adults above the age of 18 for this investigation?

"This trial is open to individuals aged 18-130, with 24 studies available for minors and 716 trials applicable to adults over 65."

Answered by AI

Is enrollment for this medical exploration still open?

"Affirmative, the information on clinicaltrials.gov indicates that this research is presently seeking volunteers. It was initially made public on March 8th 2021 and has been refreshed as of November 29th 2022. The study requires 260 individuals to enrol from 26 medical centres."

Answered by AI

What is the eligibility criteria for individuals interested in joining this research?

"The current study is recruiting 260 adult patients with hyperkalemia, aged 18-130. In order to qualify for the study individuals must meet a variety of criteria including having an eGFR ≥30 mL/min/1.73 m2, have had HK (sK+ >5.0 mEq/L) within 36 months prior and other specific factors such as receiving ACEi or ARB medications or being symptomatic HFrEF (NYHA class II-IV)."

Answered by AI

Has there been a similar study conducted in the past?

"Since 2019, Sodium zirconium cyclosilicate has been under clinical study and was first sponsored by AstraZeneca. Following a successful Phase 1 trial of 90 patients in that same year, the drug received approval for its third phase of trials. Currently, 8 different studies are being conducted across 29 nations distributed over 136 cities globally."

Answered by AI

How many medical sites are currently hosting this experiment?

"At present, patients can join the trial at 26 different medical sites spread throughout cities such as Las Vegas, Poughkeepsie and New Brunswick. To reduce travel requirements, it is beneficial to select a clinic situated closest to you."

Answered by AI

Are there any other investigations involving Sodium zirconium cyclosilicate that have been conducted?

"Sodium zirconium cyclosilicate was initially researched at Research Site in 2019, leading to 18366 completed studies. Presently, 8 investigations are active with numerous of these trials being conducted out of Las Vegas, Nevada."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Assess Efficacy and Safety of SZC for the Management of High Potassium in Patients With Symptomatic HFrEF Receiving Spironolactone

2021. "Study to Assess Efficacy and Safety of SZC for the Management of High Potassium in Patients With Symptomatic HFrEF Receiving Spironolactone". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04676646.

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