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Could this powder tame dangerous potassium levels in kids?

NCT ID NCT03813407

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 14, 2026 · Updated 5 times

Summary

This study tests a drug called sodium zirconium cyclosilicate (SZC) in about 140 children under 18 who have high potassium levels (hyperkalaemia). The drug works by trapping extra potassium in the gut so the body can get rid of it. The trial has three phases: a short correction phase to quickly lower potassium, a 28-day maintenance phase to keep it normal, and a long-term extension. Researchers are testing different doses based on age and weight to find the safest and most effective approach.

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 (SZC), a powder that binds excess potassium in the gut so it can be removed from the body
What this could lead to
If successful, this could provide a safe, effective treatment option for children with dangerously high potassium levels, helping to prevent heart problems and other complications.
What could go wrong
This is an early-phase study in children, and results from adults may not fully apply. Dosing is still being figured out, and side effects or lack of effectiveness are possible.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2019

Expected to finish

Feb 2030

An estimate. End dates often move.

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

0 to 18 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: 1. Provision of written informed consent of the participant or legal representative, and informed assent from the participant (as appropriate) 2. Female or male from birth to \< 18 years of age (for the study duration). 3. Participants (including those receiving a stable peritoneal dialysis regimen for a minimum of 2 months) requiring long-term treatment of hyperkalaemia (chronic hyperkalaemia) in the age cohort ≥ 2 years, and participants requiring either short- or long-term treatment for hyperkalaemia (acute and chronic hyperkalaemia) in the age cohort \< 2 years. 4. Participants must meet the following criteria for hyperkalaemia: Please refer to the Table 6 in the protocol. 5. Using digital ECG, QT interval corrected by Bazett's method (QTcB) must meet the age-appropriate parameters at Screening: a. For participants aged 0 to ≤ 3 days after birth: \< 450 ms b. For participants aged \>3 days to \< 12 years: \< 440 ms c. For participants aged ≥ 12 to \< 18 years: \< 450 ms (male), \< 460 ms (female) All QTcB values outside the reference values specified in the protocol should be manually re-measured and re-calculated, and if there is a difference in measurement between the automatic and manual ECG, the manual measurement should always be considered correct. 6. Ability to have repeated blood draws or effective venous catheterisation. 7. Females of childbearing potential (defined as a female with potential of becoming pregnant who has experienced her menarche) must have a negative pregnancy test within one day prior to the first dose of SZC on CP Study Day 1 and sexually active females of childbearing potential must be using 2 forms of medically acceptable contraception with at least one being a barrier method 8. Optional open-label, LTMP only: 1. Provision of written informed consent of the participant or legal representative, and informed assent from the participant (as appropriate) to take part in the LTMP. 2. Participants who are normokalaemic at the end of MP or hyperkalaemic and not on maximum dose. 3. Participants who would benefit from long-term treatment for their hyperkalaemia, as judged by the Investigator. Exclusion Criteria: 1. Neonates with a gestational age \< 37 weeks at birth or a birth weight \< 2500 g. 2. Term and preterm neonates with suspected conditions predisposing them to intestinal ischaemia (eg, perinatal hypoxia or sepsis). 3. Participants with pseudohyperkalaemia caused by excessive fist clenching to enable venepuncture, by haemolysed blood specimens, or by severe leukocytosis or thrombocytosis. 4. Participants with hyperkalaemia due to soft-tissue damage from crush injury or burns. 5. Participants with hyperkalaemia due to a secondary cause, such as dehydration, excessive use of K+ supplements, or drug use (eg, beta-adrenergic antagonists) and that would be more appropriately treated with other interventions (eg, fluid resuscitation, dose adjustments of medications). 6\. Participants with transient iatrogenic hyperkalaemia (eg, due to treatment with tacrolimus). 7\. Participants treated with lactulose, rifaximin (XIFAXAN™), or other nonabsorbed antibiotics for hyperammonaemia within the last 7 days. 8\. Participants treated with CPS, sodium polystyrene sulfonate (eg, KAYEXALATE™), or patiromer within the last 4 days prior to first dose of study treatment. 9\. Participants with a life expectancy of less than 3 months. 10. Participants who are known to have tested Human Immunodeficiency Virus (HIV) positive. 11\. Presence of any condition which, in the opinion of the Investigator, places the participant at undue risk or potentially jeopardises the quality of the data to be generated. 12. Known hypersensitivity or previous anaphylaxis to SZC or to components thereof. 13\. Participants with cardiac arrhythmias that require immediate treatment. 14. Participants with a family history of long QT syndrome. 15. Participants on haemodialysis. 16. Participants with a history of bowel obstruction. 17. Participants with severe gastrointestinal disorder or major gastrointestinal surgery (eg, large bowel resection). 18\. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). 19\. Previous treatment with SZC. 20. Treatment with a drug or device within the last 30 days prior to first dose of study treatment that has not received regulatory approval at the time of study entry. 21\. Previous enrolment in the present study. 22. Females who are pregnant, breastfeeding, or planning to become pregnant. 23. Judgement 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. 24. If the participant has evidence of Coronavirus disease 2019 (COVID-19) within 2 weeks prior to enrolment (a positive COVID-19 test or suspicion of COVID-19 infection) the participant cannot be enrolled in the study.

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Conditions

The condition(s) this trial relates to.

Hyperkalemia

As listed by the trial registrant

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

Hyperkalaemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    38 sites in 12 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • Research Site

    WITHDRAWN

    Atlanta, Georgia, 30322, United States

  • Research Site

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Research Site

    WITHDRAWN

    Grand Rapids, Michigan, 49503, United States

  • Research Site

    WITHDRAWN

    St Louis, Missouri, 63104, United States

  • Research Site

    COMPLETED

    Hackensack, New Jersey, 07601, United States

  • Research Site

    WITHDRAWN

    New York, New York, 10029, United States

  • Research Site

    WITHDRAWN

    Stony Brook, New York, 11794, United States

  • Research Site

    WITHDRAWN

    Charlotte, North Carolina, 28207, United States

  • Research Site

    WITHDRAWN

    Winston-Salem, North Carolina, 27157, United States

  • Research Site

    COMPLETED

    Akron, Ohio, 44308, United States

  • Research Site

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Research Site

    RECRUITING

    Columbia, South Carolina, 29203, United States

  • Research Site

    WITHDRAWN

    Morgantown, West Virginia, 26506-7900, United States

  • Research Site

    RECRUITING

    Campinas, 13060-904, Brazil

  • Research Site

    RECRUITING

    São Paulo, 01228-200, Brazil

  • Research Site

    RECRUITING

    São Paulo, 04038-002, Brazil

  • Research Site

    RECRUITING

    Calgary, Alberta, T3B 6A8, Canada

  • Research Site

    WITHDRAWN

    Edmonton, Alberta, T6G 1C9, Canada

  • Research Site

    WITHDRAWN

    Vancouver, British Columbia, V6H 3N1, Canada

  • Research Site

    RECRUITING

    Montreal, Quebec, H3T1C5, Canada

  • Research Site

    RECRUITING

    Beijing, 100034, China

  • Research Site

    RECRUITING

    Beijing, 100045, China

  • Research Site

    RECRUITING

    Changsha, 410007, China

  • Research Site

    RECRUITING

    Chengdu, 610000, China

  • Research Site

    RECRUITING

    Chengdu, 610041, China

  • Research Site

    RECRUITING

    Chongqing, 400014, China

  • Research Site

    RECRUITING

    Hangzhou, 310052, China

  • Research Site

    WITHDRAWN

    Hefei, 230001, China

  • Research Site

    RECRUITING

    Shanghai, 200062, China

  • Research Site

    RECRUITING

    Shanghai, 201102, China

  • Research Site

    WITHDRAWN

    Berlin, D-13353, Germany

  • Research Site

    RECRUITING

    Essen, 45147, Germany

  • Research Site

    RECRUITING

    Heidelberg, 69120, Germany

  • Research Site

    RECRUITING

    Bhubaneswar, 751019, India

  • Research Site

    RECRUITING

    Gurgaon, 122001, India

  • Research Site

    WITHDRAWN

    New Delhi, 110060, India

  • Research Site

    RECRUITING

    Bunkyō City, 113-8431, Japan

  • Research Site

    WITHDRAWN

    Fuchu-shi, 183-8561, Japan

  • Research Site

    WITHDRAWN

    Fukuoka, 813-0017, Japan

  • Research Site

    WITHDRAWN

    Kawasaki-shi, 211-8533, Japan

  • Research Site

    WITHDRAWN

    Kobe, 650-0047, Japan

  • Research Site

    WITHDRAWN

    Matsumoto-shi, 390-8621, Japan

  • Research Site

    RECRUITING

    Nakagami-gun, 903-0215, Japan

  • Research Site

    WITHDRAWN

    Saitama-Shi, 330-8777, Japan

  • Research Site

    WITHDRAWN

    Sendai, 989-3126, Japan

  • Research Site

    RECRUITING

    Shinjuku-ku, 162-8666, Japan

  • Research Site

    RECRUITING

    Shizuoka, 420-8660, Japan

  • Research Site

    COMPLETED

    Bialystok, 15-274, Poland

  • Research Site

    WITHDRAWN

    Krakow, 30-663, Poland

  • Research Site

    COMPLETED

    Lodz, 93-338, Poland

  • Research Site

    RECRUITING

    Warsaw, 02-097, Poland

  • Research Site

    RECRUITING

    Bucharest, 022322, Romania

  • Research Site

    WITHDRAWN

    Bucharest, 077120, Romania

  • Research Site

    RECRUITING

    Cluj-Napoca, 400370, Romania

  • Research Site

    WITHDRAWN

    Târgu Mureş, 540136, Romania

  • Research Site

    RECRUITING

    Timișoara, 300011, Romania

  • Research Site

    WITHDRAWN

    Samara, 443095, Russia

  • Research Site

    RECRUITING

    Esplugues de Llobregat, 08950, Spain

  • Research Site

    RECRUITING

    Madrid, 28041, Spain

  • Research Site

    SUSPENDED

    Dnipropetrovsk, 49100, Ukraine

  • Research Site

    SUSPENDED

    Kharkiv Region, 61075, Ukraine

  • Research Site

    SUSPENDED

    Kyiv, 04050, Ukraine

  • Research Site

    WITHDRAWN

    Odesa, 65038, Ukraine

  • Research Site

    SUSPENDED

    Sumy, 40031, Ukraine

  • Research Site

    COMPLETED

    Zaporizhzhya, 69063, Ukraine

  • Research Site

    RECRUITING

    Glasgow, G51 4TF, United Kingdom

  • Research Site

    RECRUITING

    Hampshire, SO16 6YD, United Kingdom

  • Research Site

    COMPLETED

    Manchester, M13 9WL, United Kingdom

  • Research Site

    TERMINATED

    Nottingham, NG7 2UH, United Kingdom

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