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New study: can a simple powder keep kidney patients out of the ER?

NCT ID NCT05347693

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether continuing a drug called sodium zirconium cyclosilicate (Lokelma) after hospital discharge helps people with chronic kidney disease maintain normal potassium levels. 186 hospitalized patients were randomly assigned to either continue the drug or receive standard care. The goal was to see if the drug reduces potassium-related hospital visits and keeps potassium in a healthy range for 180 days after discharge.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sodium zirconium cyclosilicate (Lokelma)
What this could lead to
If it works, this could show that continuing this medication after leaving the hospital helps keep potassium levels normal and reduces the need for emergency care.
What could go wrong
This is a completed phase 4 study with 186 participants, so results are available but may not apply to all patients. The open-label design means both patients and doctors knew which treatment was given, which can bias results.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

186 people

The number who actually took part.

Started

Mar 2022

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 130 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Must be 18 years of age or older, at the time of signing the informed consent * Admitted to hospital (inpatient care; directly or from ED) * With: 1. Diagnosed CKD (any stage) or 2. eGFR \< 90 ml/min/1.73 m2 at, or within 3 months of, study screening, based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (Levey et al, 2009). Note: Race/ethnicity should not be included in CKD-EPI equation calculation. * Local laboratory K+ measurement within 24 hours of baseline visit (visit 2), where result is either: * Hyperkalaemic as defined by site's local practice and K+ ≤ 6.5 mmol/L. * Or, normokalaemic: K+ between ≥ 3.5 and ≤ 5.0 mmol/L, where patient started and is receiving treatment for this episode of HK * Male or female * Capable and willing of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Exclusion Criteria: * Hospitalisation for an acute cardiovascular event within 12 weeks prior to screening * Unable to take oral SZC drug mix * With a life expectancy of less than 6 months * Any medical condition that, in the opinion of the investigator makes the participant not suitable for inclusion * QT interval corrected by the Fridericia method (QTcF) \> 550 msec * History of QT prolongation associated with other medications that required discontinuation of that medication * Congenital long QT syndrome * Clinically significant arrythmias as judged by the investigator * Ongoing treatment with SZC or patiromer before current ED visit/hospital admission (ongoing treatment with other K-binders before current ED visit/hospital admission is allowed). Note: Initiation of any SZC or patiromer during the current ED visit/hospitalisation preceding enrolment is allowed. * Chronic haemodialysis or peritoneal dialysis or the recipient of or scheduled date for a kidney transplant. Note: Emergency/unscheduled haemodialysis to treat HK during the current ED visit/hospitalisation preceding enrolment is allowed. * Participation in another clinical study with an investigational medicinal product (IMP) administered during the month before screening. * Known hypersensitivity to SZC or any of the excipients of the product * Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) * Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements * Previous randomisation in the present study * For women only: Women of child-bearing potential (WOCBP; ie, those who are not chemically or surgically sterilised or who are not post-menopausal) who are not willing to use one of the methods of contraception described hereafter, or who are not stable on the contraception method for the last one month, from the time of signing the informed consent throughout the study and 7 days after the last dose: (a) Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal (b) Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable (c) Intrauterine device (d) Intrauterine hormone-releasing system (e) Bilateral tubal occlusion (f) Vasectomised partner (vasectomised partner is a highly effective birth control method provided that partner is the sole sexual partner of the WOCBP participant and that the vasectomised partner has received medical assessment of the surgical success (g) Sexual abstinence: it is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant. * For WOCBP only: Women who have a positive pregnancy test at screening OR women who are breastfeeding.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome Hyperkalemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic kidney disease Hyperkalaemia

Contacts and locations

Locations

  • Research Site

    Bonheiden, 2820, Belgium

  • Research Site

    Leuven, 3000, Belgium

  • Research Site

    Annonay, 07103, France

  • Research Site

    Ars-Laquenexy, 57530, France

  • Research Site

    Nice, 06000, France

  • Research Site

    Saint-Priest-en-Jarez, 42270, France

  • Research Site

    Bari, 70120, Italy

  • Research Site

    Foggia, 71122, Italy

  • Research Site

    Parma, 43125, Italy

  • Research Site

    Pavia, 27100, Italy

  • Research Site

    Eindhoven, 5602 ZA, Netherlands

  • Research Site

    Algeciras, 11207, Spain

  • Research Site

    Almería, 04009, Spain

  • Research Site

    Badajoz, 06080, Spain

  • Research Site

    Barcelona, 08907, Spain

  • Research Site

    Burgos, 9006, Spain

  • Research Site

    Getafe, 28905, Spain

  • Research Site

    Madrid, 28007, Spain

  • Research Site

    Madrid, 28040, Spain

  • Research Site

    Salamanca, 37007, Spain

  • Research Site

    San Sebastián de los Reyes, 28702, Spain

  • Research Site

    Seville, 41009, Spain

  • Research Site

    Talavera de la Reina, 45600, Spain

  • Research Site

    Zamora, 49022, Spain

  • Research Site

    Doncaster, DN2 5LT, United Kingdom

  • Research Site

    Hull, HU10 7AZ, United Kingdom

  • Research Site

    Salford, M6 8HD, United Kingdom

  • Research Site

    Stevenage, SG1 4AB, United Kingdom

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