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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 week
Awards & highlights
Pivotal 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.
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.
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.

Eligibility Criteria

Inclusion Criteria

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

Timeline

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

Treatment Details

Study Objectives

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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
~15340
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
4,403 Previous Clinical Trials
289,123,509 Total Patients Enrolled
33 Trials studying Hyperkalemia
71,485 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
~382 spots leftby Jan 2026
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