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Angiotensin II Receptor Blocker

SZC for Chronic Kidney Disease (STABILIZE-CKD Trial)

Verified Trial
Phase 3
Recruiting
Led By Glenn M. Chertow, MD, MPH
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
You are one year post menopausal or are taking adequate contraception
You have hyperkalemia or are at high risk for hyperkalemia
Must not have
Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation and heart rate controlled by medication are permitted.
History of renal transplant (or anticipated need for renal transplant during the study).
Timeline
Screening 2 weeks
Treatment 24 months
Follow Up 1 weeks
Awards & highlights

STABILIZE-CKD Trial Summary

This trial will test whether a new drug, Sodium Zirconium Cyclosilicate (SZC), can help slow down kidney disease progression in people who are at risk for hyperkalaemia (high potassium levels).

Who is the study for?
This trial is for people with chronic kidney disease who also have high potassium levels or are at risk of it. They should be on RAASi therapy, have protein in their urine, and either be postmenopausal by a year or using reliable birth control. It's not for those with certain heart issues, known allergies to SZC, life expectancy under 2 years due to other diseases, uncontrolled high blood pressure, angioedema history, or past/current renal transplants.Check my eligibility
What is being tested?
The study tests if Sodium Zirconium Cyclosilicate (SZC), alongside standard ACEi/ARB treatments like lisinopril or valsartan can slow down the worsening of kidney function in patients with high potassium levels. The decline in kidney filtration rate over time will measure this effect.See study design
What are the potential side effects?
Possible side effects include digestive disturbances such as nausea or constipation since SZC works within the gut to remove excess potassium. Other potential side effects may relate to changes in body salts and fluids due to its action on potassium levels.

STABILIZE-CKD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have high potassium levels or am at risk for it.
Select...
I am currently on or have been on RAASi therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My heart condition is under control with medication.
Select...
I have had a kidney transplant or might need one during the study.

STABILIZE-CKD Trial Timeline

Screening ~ 2 weeks
Treatment ~ 24 months
Follow Up ~1 weeks
This trial's timeline: 2 weeks for screening, 24 months for treatment, and 1 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Co-primary: Total eGFR slope and Chronic eGFR slope
Secondary outcome measures
S-K level classification
Serum bicarbonate measurements
Time from randomisation to first lisinopril/valsartan dose decrease
+2 more
Other outcome measures
AEs/SAEs

STABILIZE-CKD Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Sodium Zirconium Cyclosilicate (SZC)Experimental Treatment4 Interventions
SZC 5 g every other day to 15 g once daily + Lisinopril/Valsartan
Group II: PlaceboPlacebo Group4 Interventions
Placebo + Lisinopril/Valsartan
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Irbesartan
2016
Completed Phase 4
~15260
Lisinopril
2012
Completed Phase 4
~39510
Valsartan
2016
Completed Phase 4
~10560

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,271 Previous Clinical Trials
288,611,359 Total Patients Enrolled
32 Trials studying Hyperkalemia
71,314 Patients Enrolled for Hyperkalemia
Glenn M. Chertow, MD, MPHPrincipal InvestigatorStanford University School of Medicine, Stanford, CA USA

Media Library

Irbesartan (Angiotensin II Receptor Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT05056727 — Phase 3
Hyperkalemia Research Study Groups: Placebo, Sodium Zirconium Cyclosilicate (SZC)
Hyperkalemia Clinical Trial 2023: Irbesartan Highlights & Side Effects. Trial Name: NCT05056727 — Phase 3
Irbesartan (Angiotensin II Receptor Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05056727 — Phase 3
Hyperkalemia Patient Testimony for trial: Trial Name: NCT05056727 — Phase 3

Frequently Asked Questions

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

Could you please provide a review of prior research on Lisinopril?

"Lisinopril is being studied in 59 different clinical trials, 13 of which are currently in Phase 3. The global distribution of these medical studies show that the majority are taking place in Montreal, Quebec. However, there are a total of 1818 research sites for Lisinopril spread throughout the world."

Answered by AI

Is this a fully enrolled clinical trial or are there still positions available for participants?

"The most recent information on clinicaltrials.gov suggests that this study is still looking for participants. The date of the initial posting was 9/30/2021 and there have been edits as recently as 10/27/2022."

Answered by AI

Has the FDA sanctioned Lisinopril for therapeutic use?

"Our team at Power estimates that Lisinopril is safe to use, scoring it a 3 on our safety scale. This is because there is some data supporting efficacy and multiple rounds of data supporting safety in Phase 3 trials."

Answered by AI

Can you please tell me what health conditions are commonly remedied by Lisinopril?

"Lisinopril is commonly used to myocardial infarction, but it can also offer relief for ventricular dysfunction, left essential hypertension, and hyperkalemia."

Answered by AI

How can I sign up to help with this test?

"This trial is looking for 1500 participants between the ages of 18 and 130 who currently have hyperkalemia. Participants must also meet the following criteria: Must have eGFR ≥ 25 and ≤ 59 mL/min/1.73m2 as calculated by central laboratory (CKD-EPI formula) at screening (Visit 1), Must have UACR ≥ 200 and ≤ 5000 mg/g as calculated by central laboratory at screening (Visit 1). If the first sample does not fulfil eligibility criteria, a second sample can be obtained during the screening period; if so, the UACR measurement from the second sample"

Answered by AI

Are patients above the age of 30 eligible for this trial?

"According to the eligibility requirements, any person aged 18 to 130 can enroll in this clinical trial. In contrast, there are only 39 trials for patients under 18 and 470 for those over 65."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Minnesota
Other
Illinois
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Research Site
Other
How many prior treatments have patients received?
3+
0

Why did patients apply to this trial?

For my kidney disease. My mother died from kidney disease. I have stage 4 CKD and Type 2 diabetes.
PatientReceived no prior treatments
It seemed like a trial I might benefit from.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How many trips to Chattanooga, and how often?
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Research Site: < 24 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia
2021. "A Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05056727.
All > Chronic Kidney Disease > Diovan
~588 spots leftby Jan 2026
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