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TerminatedNCT05056727STABILIZE-CKDUpdated Jan 8, 2026Results posted

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

A Phase 3 interventional study of Sodium Zirconium Cyclosilicate (SZC) and Placebo in Renal Insufficiency, Chronic and Hyperkalemia, sponsored by AstraZeneca. Terminated at 276 sites in 21 countries. Open to participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2026-01-08.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Why this study was terminated
The study started enrollment in Sep 2021 and despite huge efforts the rate of patient enrollment continued to be below target such that the completion of the study within a reasonable timeframe was deemed very unlikely.
Phase
Phase 3
Study type
Interventional
Enrollment
1,112
Allocation
Randomized
Ages
18 Years to 130 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the effect of Sodium Zirconium Cyclosilicate (SZC), as adjunct to ACEi/ARB therapy (lisinopril or valsartan), on slowing CKD progression (assessed as the reduction in participant's glomerular filtration rate [eGFR] decline over time) in participants with hyperkalaemia or at high risk of hyperkalaemia.

Read the detailed description

This is a Phase 3, international, randomised withdrawal, double-blind, parallel-group, placebo-controlled study, to evaluate the effect of SZC as adjunct to RAASi therapy (lisinopril or valsartan) in slowing CKD progression in participants with CKD and hyperkalaemia or at risk of hyperkalaemia.

Specifically, the study will include participants with hyperkalaemia (S-K > 5.0 to ≤ 6.5 mmol/L by central laboratory) who are on adequate or limited RAASi therapy due to hyperkalaemia, and participants with normokalaemia (S-K ≥ 3.5 to ≤ 5.0 mmol/L by central laboratory) who are on limited RAASi therapy due to high risk of hyperkalaemia. High risk of hyperkalaemia is defined as (1) participants with a previous medical history or record of hyperkalaemia within the prior 24 months who are on limited RAASi therapy despite indication in CKD; (2) participants in whom RAASi therapy is indicated in CKD but are on limited RAASi therapy and have S-K ≥ 4.7 to ≤ 5.0 mmol/L; and (3) participants in whom RAASi therapy has been discontinued or reduced to suboptimal doses because of hyperkalaemia.

A participant is expected to be in the study for approximately 28 months, which includes up to 13 days for the screening period, 27 months for the intervention period, and 1 week for follow-up. The 27-month intervention period of the study consists of 3 phases, an initiation phase (up to 72 hours), a run-in phase (3 months/up to Day 90), and a maintenance phase (24 months/104 weeks).

The initial dose of SZC will be administered to participants during the initiation phase. No changes will be made to the ACEi or ARB therapy at this stage. As soon as possible after the participant is confirmed to be normokalaemic at the end of the initiation phase, the participant will enter the run-in phase. Participants will receive open-label SZC and either lisinopril or valsartan. The aim of the run-in phase is to increase ACEi or ARB therapy stepwise to their maximum doses. After a 3-month run-in period for RAASi dose optimization while on SZC, participants will be randomized to SZC or placebo and followed during the subsequent 24 months of maintenance phase for efficacy and safety assessments.

02

Conditions studied

  • Renal Insufficiency, Chronic
  • Hyperkalemia

Keywords

  • Renal Insufficiency, Chronic
  • Chronic Kidney Diseases
  • Hyperkalemia
03

In context

Renal Insufficiency, Chronic

3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.

This study's enrollment of 1,112 is above the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.

Browse AstraZeneca studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 130 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Capable of giving signed which includes compliance with the requirements and restrictions listed in the ICF and protocol
  • Must be ≥ 18 years of age at the time of signing the informed consent.
  • Must have ≥ 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 must be within the eligibility range.

  • Any of the following criteria, a or b, at screening (Visit 1):

    1. Cohort A: Hyperkalaemia (S-K > 5.0 to ≤ 6.5 mmol/L) as measured by the central laboratory, and on adequate* or limited** RAASi therapy due to hyperkalaemia.
    2. Cohort B: Normokalaemia (S-K ≥ 3.5 to ≤ 5.0 mmol/L) as measured by the central laboratory and on limited** RAASi therapy due to high risk of hyperkalaemia. High risk of hyperkalaemia is defined as:

    (i) Participants with a previous medical history or record of hyperkalaemia within the prior 24 months, who are on limited** RAASi therapy despite indication in CKD.

(ii) Participants in whom RAASi therapy is indicated in CKD, who are on limited** RAASi therapy and have S-K ≥ 4.7 to ≤ 5.0 mmol/L.

(iii) Participants in whom RAASi therapy has been discontinued or reduced to suboptimal* doses because of hyperkalaemia.

*Adequate RAASi dose levels are defined in protocol; doses lower than these are considered as suboptimal.

**Limited RAASi therapy is defined as no or suboptimal RAASi therapy according to dosing guidance provided in protocol.

  • If on thiazide or loop diuretics, the dose must have been stable for 2 weeks prior to screening (Visit 1).
  • If on RAASi therapy, the dose must have been stable for one month prior to screening (Visit 1) and remain stable during screening.
  • If on an SGLT2i treatment (ie, dapagliflozin and canagliflozin), finerenone, or any other medications in these 2 classes that are approved for CKD, the dose must have been stable for 3 months prior to screening (Visit 1).
  • Participants must be one-year , surgically sterile, or using one highly effective form of (defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly). They should have been stable on their chosen method of birth control for a minimum of one month prior to screening (Visit 1) and willing to remain on the birth control until one month after the last dose of study intervention.

Exclusion criteria

Exclusion Criteria:

  • class III to IV congestive heart failure at the time of screening (Visit 1) or previous history of severe or symptomatic heart failure.
  • Myocardial infarction, unstable angina, stroke, or within 3 months prior to screening (Visit 1).
  • Participants with a known history of systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 95 mmHg within 2 weeks prior to screening (Visit 1) are excluded. In addition, any participant with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 95 mmHg as measured at screening (Visit 1) and confirmed by repeated measurement is excluded. Participants may be rescreened once blood pressure is controlled.
  • > 550 msec at screening (Visit 1).
  • History of QT prolongation associated with other medications that required discontinuation of that medication.
  • Congenital long QT syndrome.
  • Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation and heart rate controlled by medication are permitted.
  • Lupus nephritis or anti-neutrophil cytoplasmic antibody-associated vasculitis.
  • Change in renal function requiring hospitalisation or dialysis within 3 months prior to screening (Visit 1).
  • History of renal transplant (or anticipated need for renal transplant during the study).
  • Severe hepatic impairment, biliary cirrhosis, or cholestasis.
  • History of hereditary or idiopathic angioedema.
  • Any prior to ACEi or ARB that in the investigator's judgment precludes use of lisinopril and valsartan/irbesartan. Prior hypersensitivity reactions to consider include, but are not limited to, development of angioedema, icterus, hepatitis, or neutropaenia or thrombocytopaenia requiring treatment modification.
  • Known hypersensitivity or previous anaphylaxis to SZC or to components thereof.
  • Any condition outside the CV and renal disease area such as, but not limited to, , with a of less than 2 years based on investigator´s clinical judgment.
  • Active malignancy requiring treatment at the time of screening (Visit 1), except for successfully treated basal cell or treated squamous cell carcinoma.
  • S-K > 6.5 or \< 3.5 mmol/L by local laboratory within 1 day prior to the scheduled first dose of SZC in the initiation phase.
  • Evidence of COVID-19 infection within 2 weeks prior to screening (Visit 1).
  • Treated with dual blockade of RAAS (combined use of an ACEi and ARB) within 3 months prior to screening (Visit 1).
  • Treated with an angiotensin receptor neprilysin inhibitor (ARNI; sacubitril/valsartan [Entresto®]) within 3 months prior to screening (Visit 1).
  • Treated with an MRA not approved for CKD within 3 months prior to screening (Visit 1).
  • Treated with aliskiren-containing products with 3 months prior to screening (Visit 1).
  • Treated with SPS (eg, Kayexalate, Resonium), CPS (Resonium Calcium), patiromer (Veltassa®), or SZC (Lokelma®) within 7 days prior to screening (Visit 1).
  • Participation in another clinical study with an product administered within one month prior to screening (Visit 1).
  • Not willing or not able to change to lisinopril or valsartan/irbesartan, the protocol-mandated RAASi study intervention. Note: For participants taking a fixed combination of an ACEi or ARB with another agent (eg, calcium blockers or diuretics) as SoC, the investigator must make a judgment that it will be safe and efficacious for such participants to change to the study ACEi or ARB and to the other drug as separate agents.
  • Previous dosing with SZC in the present study.
  • Currently pregnant (confirmed with positive pregnancy test at screening [Visit 1]) or breastfeeding.
  • Judgment by the investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements.
  • Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,112 participants (actual)

Study arms

  • Experimental
    Sodium Zirconium Cyclosilicate (SZC)

    SZC 5 g every other day to 15 g once daily + Lisinopril/Valsartan

    Drug: Sodium Zirconium Cyclosilicate (SZC) · Drug: Lisinopril · Drug: Valsartan · Drug: Irbesartan

  • Placebo comparator
    Placebo

    Placebo + Lisinopril/Valsartan

    Drug: Placebo · Drug: Lisinopril · Drug: Valsartan · Drug: Irbesartan

Interventions

  • DrugSodium Zirconium Cyclosilicate (SZC)

    Powder for oral suspension in a sachet. Unit dose strength: 5 or 10 g SZC. Single dose will consist of 1-3 sachets. During Initiation Phase: * S-K \> 5 to ≤ 6.5 mmol/L (measured by L-Lab): Single dose contains 10 g SZC that should be suspended in 45 mL of water. The 10 g SZC single dose should be administered three times daily for up to 72 hours until normokalaemic (S-K 3.5-5.0 mmol/L); the total daily dose is 30 g SZC. * S-K ≥ 3.5 to ≤ 5 mmol/L (measured by L-Lab): Single dose contains 5 g SZC that should be suspended in 45 mL of water and administered once daily for 48 hours. During Run-in and Maintenance Phases: \- Single dose contains 5 g SZC administered every other day or 5, 10, or 15 g SZC administered once daily that should be suspended in 45 mL of water.

    Also known as: Lokelma TM

  • DrugPlacebo

    Powder for oral suspension in a sachet. Placebo to match 5 or 10 g. Single dose will consist of 1-3 sachets. During Maintenance Phase: \- Single dose contains 5 g placebo administered every other day or 5, 10, or 15 g placebo administered once daily that should be suspended in 45 mL of water.

  • DrugLisinopril

    Tablet for oral administration. Unit dose strength: 2.5, 5, 10 or 20 mg. Dosage level: 5, 10, 20, or 40 mg administered once daily.

  • DrugValsartan

    Tablet or capsule for oral administration. Unit dose strength: 40, 80 or 160 mg. Dosage level: 40, 80, 160, or 320 mg administered once daily.

  • DrugIrbesartan

    Tablet for oral administration. Unit dose strength: 75, 150 or 300 mg. Dosage level: 75, 150, or 300 mg administered once daily. The study is designed to use valsartan as the selected ARB therapy adjunct to SZC. However, if an actual shortage of valsartan in a local market jeopardises the ability of participants to enter or continue in the study, valsartan can be temporarily substituted with irbesartan until the shortage of valsartan is resolved.

06

What researchers measure

Primary outcomes

  1. Total eGFR Slope (Coprimary Analysis #1)

    Total eGFR slope, Baseline (Maintenance phase) to visit 17 (week 69)

    Time frame: Baseline (Maintenance phase) to visit 17 (week 69)

  2. Chronic eGFR Slope (Coprimary Analysis #2)

    Chronic eGFR slope, 12 weeks to visit 17 (week 69)

    Time frame: 12 weeks to visit 17 (week 69)

Secondary outcomes

  1. Incidence of the Composite of Kidney Failure Outcomes

    Incidence of the composite of kidney failure outcomes comprising: sustained ≥ 40% decline in eGFR, onset of ESKD, and death from kidney failure is analyzed based on Cox regression model. Patients with no events are censored at end of maintenance phase or premature discontinuation.

    Time frame: From Baseline (Maintenance phase) up to week 97 (Maintenance phase)

  2. Incidence of RAASi Reduction

    Incidence of RAASi (lisinopril/valsartan) dose decrease is analyzed based on Cox regression model. Patients with no events are censored at end of maintenance phase or premature discontinuation.

    Time frame: From Baseline (Maintenance phase) up to week 97 (Maintenance phase)

  3. UACR

    Urine albumin-to-creatinine ratio (UACR); mass concentration of albumin divided by mass concentration of creatinine, in urine; at visit 13 (week 24)

    Time frame: At visit 13 (week 24)

07

Results

Posted Jan 8, 2026
Limitations and caveats
The study was terminated early due to recruitment challenges (not safety concerns). The ensuing small number of fully evaluable subjects (716 randomized vs planned 1360) and short follow up (mean 8 - 9 months vs planned 24 months) had a heavy negative impact on the formal statistical analyses, especially slope analyses, and therefore preclude any meaningful conclusions on eGFR slopes.

Participant flow

The study was conducted from 30 September 2021 to 07 February 2024 at 286 sites in 20 countries worldwide.

Initiation Phase
Participant flow — Initiation Phase
MilestoneInitiation PhaseRun-in PhaseMaintenance Phase: SZCMaintenance Phase: Placebo
Started1112000
Completed1078000
Not completed34000
Withdrew: Lost to follow-up1000
Withdrew: Study-specific; study terminated; other20000
Withdrew: Withdrawal by subject9000
Withdrew: Physician decision4000
Run-in Phase
Participant flow — Run-in Phase
MilestoneInitiation PhaseRun-in PhaseMaintenance Phase: SZCMaintenance Phase: Placebo
Started0104900
Completed076300
Not completed028600
Withdrew: Study-specific; site terminated; screen failure; study terminated; other023700
Withdrew: Death0300
Withdrew: Withdrawal by subject02500
Withdrew: Physician decision02000
Withdrew: Lost to follow-up0100
Maintenance Phase
Participant flow — Maintenance Phase
MilestoneInitiation PhaseRun-in PhaseMaintenance Phase: SZCMaintenance Phase: Placebo
Started00361355
Completed0000
Not completed00361355
Withdrew: Site terminated; study terminated; other00332314
Withdrew: Withdrawal by subject001921
Withdrew: Physician decision00416
Withdrew: Lost to follow-up0022
Withdrew: Death0042

Outcome measures

PrimaryTotal eGFR Slope (Coprimary Analysis #1)

Total eGFR slope, Baseline (Maintenance phase) to visit 17 (week 69)

Time frame:
Baseline (Maintenance phase) to visit 17 (week 69)
Reported as:
Least squares mean · mL/min/(1.73 m2)/yr
Total eGFR Slope (Coprimary Analysis #1)
mL/min/(1.73 m2)/yrMaintenance Phase: SZCMaintenance Phase: Placebo
Total eGFR Slope (Coprimary Analysis #1)-5.2975 (-6.6854 to -3.9097)-4.5622 (-5.9969 to -3.1275)
Statistical analysis
  • Maintenance Phase: SZC vs Maintenance Phase: Placebo · Mixed Models Analysis · p = 0.4691 (Test of no treatment difference in mean total eGFR-slope) · Treatment difference in mean slope: -0.7354 · 95% CI -2.7311 to 1.2604SZC minus Placebo
PrimaryChronic eGFR Slope (Coprimary Analysis #2)

Chronic eGFR slope, 12 weeks to visit 17 (week 69)

Time frame:
12 weeks to visit 17 (week 69)
Reported as:
Least squares mean · mL/min/(1.73 m2)/yr
Chronic eGFR Slope (Coprimary Analysis #2)
mL/min/(1.73 m2)/yrMaintenance Phase: SZCMaintenance Phase: Placebo
Chronic eGFR Slope (Coprimary Analysis #2)-4.8705 (-6.7222 to -3.0189)-2.8285 (-4.7571 to -0.8999)
Statistical analysis
  • Maintenance Phase: SZC vs Maintenance Phase: Placebo · Mixed Models Analysis · p = 0.1338 · Treatment difference in mean slope: -2.0421 · 95% CI -4.7156 to 0.6314SZC minus Placebo
SecondaryIncidence of the Composite of Kidney Failure Outcomes

Incidence of the composite of kidney failure outcomes comprising: sustained ≥ 40% decline in eGFR, onset of ESKD, and death from kidney failure is analyzed based on Cox regression model. Patients with no events are censored at end of maintenance phase or premature discontinuation.

Time frame:
From Baseline (Maintenance phase) up to week 97 (Maintenance phase)
Reported as:
Count of participants · Participants
Incidence of the Composite of Kidney Failure Outcomes
ParticipantsMaintenance Phase: SZCMaintenance Phase: Placebo
Incidence of the Composite of Kidney Failure Outcomes74
Statistical analysis
  • Maintenance Phase: SZC vs Maintenance Phase: Placebo · Regression, Cox · p = 0.390 · Hazard ratio (hr): 1.72 · 95% CI 0.50 to 5.90SZC relative to Placebo
SecondaryIncidence of RAASi Reduction

Incidence of RAASi (lisinopril/valsartan) dose decrease is analyzed based on Cox regression model. Patients with no events are censored at end of maintenance phase or premature discontinuation.

Time frame:
From Baseline (Maintenance phase) up to week 97 (Maintenance phase)
Reported as:
Count of participants · Participants
Incidence of RAASi Reduction
ParticipantsMaintenance Phase: SZCMaintenance Phase: Placebo
Incidence of RAASi Reduction55128
Statistical analysis
  • Maintenance Phase: SZC vs Maintenance Phase: Placebo · Regression, Cox · p = <0.001 · Hazard ratio (hr): 0.34 · 95% CI 0.25 to 0.47SZC relative to Placebo
SecondaryUACR

Urine albumin-to-creatinine ratio (UACR); mass concentration of albumin divided by mass concentration of creatinine, in urine; at visit 13 (week 24)

Time frame:
At visit 13 (week 24)
Reported as:
Least squares mean · mg/g
UACR
mg/gMaintenance Phase: SZCMaintenance Phase: Placebo
UACR1513.07 (1253.89 to 1772.24)1211.94 (943.14 to 1480.74)
Statistical analysis
  • Maintenance Phase: SZC vs Maintenance Phase: Placebo · Regression, Linear · p = 0.034 · Mean difference: 301.1 · 95% CI 23.15 to 579.11SZC minus Placebo

Adverse events

Collected over Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase). Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Initiation Phase0/1,112 (0%)0/1,112 (0%)12/1,112 (1.1%)
Run-in Phase3/1,049 (0.3%)56/1,049 (5.3%)221/1,049 (21.1%)
Maintenance Phase: SZC4/359 (1.1%)66/359 (18.4%)106/359 (29.5%)
Maintenance Phase: Placebo2/355 (0.6%)42/355 (11.8%)120/355 (33.8%)
Most frequent serious events
Showing 10 of 145
Most frequent serious events
EventInitiation PhaseRun-in PhaseMaintenance Phase: SZCMaintenance Phase: Placebo
Acute kidney injuryRenal and urinary disorders0/11120/10496/3593/355
Cardiac failure acuteCardiac disorders0/11122/10495/3590/355
PneumoniaInfections and infestations0/11124/10494/3590/355
CellulitisInfections and infestations0/11120/10491/3593/355
OsteomyelitisInfections and infestations0/11120/10490/3593/355
HyperkalaemiaMetabolism and nutrition disorders0/11120/10493/3593/355
Chronic kidney diseaseRenal and urinary disorders0/11121/10493/3591/355
HypertensionVascular disorders0/11123/10493/3591/355
Coronary artery diseaseCardiac disorders0/11120/10490/3592/355
CholecystitisHepatobiliary disorders0/11120/10490/3592/355
Most frequent other events
Most frequent other events
EventInitiation PhaseRun-in PhaseMaintenance Phase: SZCMaintenance Phase: Placebo
HyperkalaemiaMetabolism and nutrition disorders4/111216/104923/35993/355
HypokalaemiaMetabolism and nutrition disorders0/111282/104944/3591/355
HypertensionVascular disorders0/111248/104918/35913/355
Oedema peripheralGeneral disorders2/111238/104918/3596/355
HypotensionVascular disorders0/111218/104912/3597/355
DiarrhoeaGastrointestinal disorders2/111214/104912/3597/355
Covid-19Infections and infestations0/111215/104912/3598/355
ConstipationGastrointestinal disorders3/111230/104911/3593/355
NasopharyngitisInfections and infestations1/11127/104911/3596/355

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Maintenance Phase: SZCMaintenance Phase: PlaceboTotal
Mean64.5 ± 12.363.6 ± 11.964.0 ± 12.1
Age, Customized
Age, Customized(Participants)Maintenance Phase: SZCMaintenance Phase: PlaceboTotal
18 yr ≤ Age < 65 yr163168331
Age ≥ 65 yr198187385
Sex: Female, Male
Sex: Female, Male(Participants)Maintenance Phase: SZCMaintenance Phase: PlaceboTotal
Female122132254
Male239223462
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Maintenance Phase: SZCMaintenance Phase: PlaceboTotal
Hispanic or Latino6579144
Not Hispanic or Latino296276572
Unknown or Not Reported000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Maintenance Phase: SZCMaintenance Phase: PlaceboTotal
Asian140133273
Black or African American121325
White193192385
Other121426
Unknown or Not Reported437
UACR
UACR(mg/g)Maintenance Phase: SZCMaintenance Phase: PlaceboTotal
Median1032.5 (419.0 to 2119.0)1017.0 (440.0 to 2056.0)1018.0 (439.0 to 2088.0)
eGFR
eGFR(mL/min/(1.73 m2))Maintenance Phase: SZCMaintenance Phase: PlaceboTotal
Mean41.0 ± 12.940.4 ± 12.440.7 ± 12.6
S-K
S-K(mmol/L)Maintenance Phase: SZCMaintenance Phase: PlaceboTotal
Mean4.41 ± 0.434.45 ± 0.484.43 ± 0.46
08

Study locations

276 sites
  • Research Site
    Surprise, Arizona 85374, United States
  • Research Site
    Tucson, Arizona 85741, United States
  • Research Site
    Canyon Country, California 91351, United States
  • Research Site
    Chula Vista, California 91910, United States
  • Research Site
    Northridge, California 91324, United States
  • Research Site
    San Dimas, California 91773, United States
  • Research Site
    South Gate, California 90280, United States
  • Research Site
    Tarzana, California 91356, United States
  • Research Site
    Denver, Colorado 80230, United States
  • Research Site
    Boynton Beach, Florida 33435, United States
  • Research Site
    Hialeah, Florida 33012, United States
  • Research Site
    Lauderdale Lakes, Florida 33313, United States
  • Research Site
    Ocoee, Florida 34761, United States
  • Research Site
    Temple Terrace, Florida 33637, United States
  • Research Site
    Nampa, Idaho 83687, United States
  • Research Site
    Chicago, Illinois 60643, United States
  • Research Site
    Oak Brook, Illinois 60523, United States
  • Research Site
    Fort Wayne, Indiana 46804, United States
  • Research Site
    Louisville, Kentucky 40205, United States
  • Research Site
    Boston, Massachusetts 02114, United States
  • Research Site
    Boston, Massachusetts 02115, United States
  • Research Site
    Flint, Michigan 48532, United States
  • Research Site
    Saint Clair Shores, Michigan 48081, United States
  • Research Site
    Columbia, Missouri 65201, United States
  • Research Site
    Kansas City, Missouri 64111, United States
  • Research Site
    Albuquerque, New Mexico 87109, United States
  • Research Site
    Albany, New York 12205, United States
  • Research Site
    Great Neck, New York 11021, United States
  • Research Site
    Winston-Salem, North Carolina 27103, United States
  • Research Site
    Cincinnati, Ohio 45267, United States
  • Research Site
    Bethlehem, Pennsylvania 18017, United States
  • Research Site
    Chester, Pennsylvania 19013, United States
  • Research Site
    Columbia, South Carolina 29203, United States
  • Research Site
    Orangeburg, South Carolina 29118, United States
  • Research Site
    Chattanooga, Tennessee 37404, United States
  • Research Site
    Arlington, Texas 76015, United States
  • Research Site
    Fort Worth, Texas 76164, United States
  • Research Site
    Houston, Texas 77004, United States
  • Research Site
    Houston, Texas 77054, United States
  • Research Site
    Houston, Texas 77099, United States
  • Research Site
    San Antonio, Texas 78212, United States
  • Research Site
    Newport News, Virginia 23606, United States
  • Research Site
    Buenos Aires, ARG 1425, Argentina
  • Research Site
    Buenos Aires, C1429BWN, Argentina
  • Research Site
    CABA, C1440AAD, Argentina
  • Research Site
    La Plata, 1900, Argentina
  • Research Site
    Mar del Plata, 7600, Argentina
  • Research Site
    Mar del Plata, B7600, Argentina
  • Research Site
    Rosario, 2000, Argentina
  • Research Site
    San Vicente, 5006, Argentina
  • Research Site
    Sarandí, B1872EEC, Argentina
  • Research Site
    Curitiba, 80440-020, Brazil
  • Research Site
    Fortaleza, 60115282, Brazil
  • Research Site
    Joinville, 89227-680, Brazil
  • Research Site
    Maringá, 87060-040, Brazil
  • Research Site
    Porto Alegre, 90020-090, Brazil
  • Research Site
    Porto Alegre, 90160-093, Brazil
  • Research Site
    São Paulo, 04039-000, Brazil
  • Research Site
    São Paulo, 05403-9000, Brazil
  • Research Site
    Blagoevgrad, 2700, Bulgaria
  • Research Site
    Botevgrad, 2140, Bulgaria
  • Research Site
    Dupnitsa, 2600, Bulgaria
  • Research Site
    Gorna Oryahovitsa, 5100, Bulgaria
  • Research Site
    Gotse Delchev, 2900, Bulgaria
  • Research Site
    Kozloduy, 3320, Bulgaria
  • Research Site
    Lom, 3600, Bulgaria
  • Research Site
    Pleven, 5800, Bulgaria
  • Research Site
    Plovdiv, 4000, Bulgaria
  • Research Site
    Plovdiv, 4001, Bulgaria
  • Research Site
    Plovdiv, 4004, Bulgaria
  • Research Site
    Samokov, 2000, Bulgaria
  • Research Site
    Sandanski, 2800, Bulgaria
  • Research Site
    Silistra, 7500, Bulgaria
  • Research Site
    Sliven, 8800, Bulgaria
  • Research Site
    Smolyan, 3700, Bulgaria
  • Research Site
    Stara Zagora, 6000, Bulgaria
  • Research Site
    Yambol, 8600, Bulgaria
  • Research Site
    Saint John, New Brunswick E2L 4L2, Canada
  • Research Site
    Oshawa, Ontario L1G 2B9, Canada
  • Research Site
    Montreal, Quebec H1T 2M4, Canada
  • Research Site
    Montreal, Quebec H4J 1C5, Canada
  • Research Site
    Baotou, 014010, China
  • Research Site
    Beijing, 100029, China
  • Research Site
    Beijing, 100034, China
  • Research Site
    Beijing, 100044, China
  • Research Site
    Beijing, 100191, China
  • Research Site
    Beijing, 102206, China
  • Research Site
    Beijing, 102218, China
  • Research Site
    Changchun, 130041, China
  • Research Site
    Changsha, 410013, China
  • Research Site
    Chengdu, 610041, China
  • Research Site
    Chengdu, 610072, China
  • Research Site
    Chongqing, 400010, China
  • Research Site
    Guangzhou, 510000, China
  • Research Site
    Guangzhou, 510062, China
  • Research Site
    Guangzhou, 510180, China
  • Research Site
    Guangzhou, 510630, China
  • Research Site
    Guiyang, 550002, China
  • Research Site
    Hangzhou, 310014, China
  • Research Site
    Hefei, 230601, China

Showing the first 100 of 276 sites across 21 countries. Choose a country and city above to see the rest.

09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting information: Study protocol, Statistical analysis plan

Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Access criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Data sharing details ↗ · astrazenecagroup-dt.pharmacm.com

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2021 to primary completion in Feb 2024, 28 months.

Results were first posted in Jan 2026, 1 year 11 months after primary completion. A results delay was requested in Dec 2024.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 1, 2021
First posted
Sep 24, 2021
StartActual
Sep 30, 2021
Primary completionActual
Feb 7, 2024
CompletionActual
Feb 7, 2024
Results delay requested
Dec 16, 2024
Results first posted
Jan 8, 2026
Last update
Jan 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05056727
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Sep 24, 2021
Start date
Sep 30, 2021
Primary completion
Feb 7, 2024
Completion
Feb 7, 2024
Results posted
Jan 8, 2026
Last update
Jan 8, 2026

Study contacts

Glenn M. Chertow, MD, MPH
principal investigator · Stanford University School of Medicine, Stanford, CA USA

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Sodium zirconium cyclosilicate

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