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New hope for kids with dangerous potassium levels

NCT ID NCT05766839

Disease control Sponsor: Vifor Pharma, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 21, 2026 · Updated 3 times

Summary

This study tests a medicine called patiromer to see if it safely lowers high potassium levels in children under 12. High potassium can be harmful, especially for kids with kidney problems. The study will check how well the medicine works and monitor for side effects in 32 children.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 36 people

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

Started

Apr 2025

Expected to finish

Dec 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 11 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: * Paediatric participants (\<12 years of age) with hyperkalaemia at screening. * Participant's age should not reach 12 years during the 28 days of the pharmacodynamic/dose-ranging period. * Participant is able to receive regular external feeding and medication, including via tubes, i.e., percutaneous endoscopic gastrostomy (PEG) or entero-gastric feeding tube. * At screening/baseline, the results from 2 separate and consecutive potassium assessments using the same measurement method (whole blood, plasma, or serum) need to be above the age-appropriate upper limit of normal (ULN). * In continuation to above criterion: At least 1 sample needs to be taken at screening/baseline and 1 sample should not be older than 30 days, i.e., a historical sample. The average of the 2 potassium values needs to be above the age-appropriate ULN of the measurement method plus 0.5 mEq/l (equivalent to 0.5 mmol/l). If the 2 samples are taken on the day of screening/baseline, the 2 individual potassium values must not differ from each other by more than 0.5 mEq/l. * In the opinion of the Investigator, the participant is expected to require treatment for hyperkalaemia for at least 28 days upon enrolment in the study. * If taking any renin-angiotensin aldosterone system inhibitors (RAASi), beta blockers, fludrocortisone, or diuretic medications, must be on a stable dose for at least 14 days prior to screening. * Parent(s) or legally acceptable representative(s) has provided the appropriate written informed consent, in accordance with local regulations. The assent of the child should also be obtained when appropriate or if requested by the Institutional Review Board (IRB)/Ethics Committee (EC)/Independent Ethics Committee (IEC). The written informed consent must be provided before any study specific procedures are performed including screening procedures. * Parent(s) or legally authorised representative(s) or another appropriate person delegated by the legally authorised representatives must be available to help the study-site personnel ensure follow-up; accompany the participant to the study site on each assessment day according to the Schedule of Events (Table 1, Table 2) (e.g., able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures); accurately and reliably dispense investigational product as directed. * Not applicable to Norway sites: Females of childbearing potential must be non-lactating, must have a negative pregnancy test at screening; and must have used an effective, acceptable form of contraception (e.g., abstinence) for at least 1 month before patiromer administration. Females of childbearing potential must agree to continue using contraception throughout the study and for 1 month after the last dose of patiromer. * If undergoing peritoneal dialysis, participants must be on a stable treatment plan for a minimum of 4 weeks prior to screening, or at least 8 weeks prior to screening if newly initiated on peritoneal dialysis. * For participants who have undergone organ transplantation, the general clinical condition must be stable for at least 4 weeks prior to Screening and is not expected to change during the first 4 weeks of the study. * For participants who have undergone organ transplantation, must have persistent hyperkalaemia requiring potassium-lowering therapy despite correction of reversible causes (e.g., high calcineurin inhibitor levels). Exclusion Criteria: * Preterm birth infants with \<37 weeks of gestation cannot be included in Cohort 3. * Participants who due to their general condition, e.g., anaemia or low body weight, are not suitable to have blood volume withdrawn as specified in the Schedule of Events. * Participants with pseudo-hyperkalaemia due to haemolysis or to abnormally high numbers of platelets (above ULN), leukocytes (above ULN), or erythrocytes (above ULN) at screening based on results obtained from the local laboratory. * Any participant with evidence of potential potassium-related 12-lead electrocardiogram (ECG) changes (i.e., changes consistent with hyper- or hypokalaemia) at screening. * Any participant with serum magnesium \<1.4 mg/dl (0.58 mmol/l) at screening/baseline. * Any of the following renal conditions: maintenance haemodialysis, renal artery stenosis, and acute kidney injury (defined by 2012 Kidney Disease Improving Global Outcomes) or a history of acute renal insufficiency in the past 3 months. Note: Chronic kidney disease (CKD) is not excluded. * A history of or current diagnosis of a severe gastrointestinal (GI) diagnosis or surgery that could affect GI transit of the drug (delayed gastric emptying), such as a severe swallowing disorder, severe gastroesophageal reflux, uncorrected pyloric stenosis, intussusception, any other intestinal obstruction (e.g., Hirschsprung disease, chronic intestinal pseudo-obstruction, clinically significant postsurgical abdominal adhesions) or any gut-shortening surgical procedure prior to screening. * In continuation to above criterion: Pre-gastric above-mentioned pathologies may be disregarded in case of existence of a PEG or entero-gastric feeding tube, as the PEG or entero-gastric feeding tube will serve for nutrition and investigational product administration. * Liver enzymes (alanine aminotransferase or aspartate aminotransferase) more than 3 times the ULN at screening, based on the local laboratory, as well as the participant's respective age. * Active cancer, currently on cancer treatment, or history of cancer in the past 2 years (except for non-melanoma skin cancer). * Scheduled for kidney transplant procedure during the first 28 days after Day 1. * History of sudden infant death in a sibling (only for participants \<2 years of age at screening). * Has severe hypoxaemia, respiratory acidosis, asphyxia, or hypotension 3 months before screening based on assessment of the Investigator. * Participants treated with sodium polystyrene sulphonate, calcium polystyrene sulphonate, sodium zirconium cyclosilicate, or patiromer within the last 48 hours prior to fulfilling the baseline baseline potassium assessments requested in 4th Inclusion Criterion. * Use of the following medications if doses have not been stable for at least 14 days prior to screening or if doses are anticipated to change during the 4-week pharmacodynamic/ dose-ranging period: digoxin, bronchodilators, theophylline, heparins (including low molecular heparins), tacrolimus, mycophenolate mofetil, cyclosporine, trimethoprim, or cotrimoxazole. * Use of any investigational product for an unapproved indication within 30 days prior to screening or within 5 half-lives, whichever is longer. * Known hypersensitivity to patiromer or its components. * In the opinion of the Investigator, parent(s) or legal representative(s) inability to comply with the protocol. * In the opinion of the Investigator, any medical condition, uncontrolled systemic disease, or serious intercurrent illness that would significantly decrease study compliance or jeopardise the safety of the participant or potentially affect the quality of the data such as: * In continuation to above criterion: hyperkalaemia at screening that requires emergency intervention; cardiovascular event or intervention within 3 months prior to screening; a haemodynamically unstable arrhythmia; hospitalisation for heart failure within the past 3 months; poorly controlled blood pressure; poorly controlled diabetes mellitus or frequent need for adjustment in insulin prescription or recent hospitalisation for treatment of hyper or hypoglycaemia. * If the child is being breastfed: 1. There is suspicion of current alcohol or substance misuse/abuse in breastfeeding mother. 2. The breastfeeding mother is taking potassium supplements

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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.

Hyperkalemia

How to take part

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

  1. The places running it

    35 sites in 15 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

  • Al Jalila Children's Hospital

    RECRUITING

    Dubai, United Arab Emirates

  • Arnold Palmer Hospital for Children

    RECRUITING

    Orlando, Florida, 32806, United States

  • Assistance Publique-Hopitaux de Paris Robert-Debre

    RECRUITING

    Paris, 75019, France

  • Augusta University - Children's Hospital of Georgia

    RECRUITING

    Augusta, Georgia, 30912, United States

  • Boston Children's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • CHRU Montpellier - Arnaud de Villeneuve

    RECRUITING

    Montpellier, 34090, France

  • Children's Hospital Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Children's Hospital Westmead Centre for Kidney Research

    RECRUITING

    Westmead, 2145, Australia

  • Children's Mercy Hospitals and Clinics

    RECRUITING

    Kansas City, Missouri, 64108, United States

  • Duke University Hospital

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    RECRUITING

    Milan, 20122, Italy

  • Helse Bergen HF Haukeland Universitetssjukehus

    RECRUITING

    Bergen, 5009, Norway

  • Helsingin Yliopistollinen Keskussairaala Uusi Lastensairaala

    NOT_YET_RECRUITING

    Helsinki, 00290, Finland

  • Hôpital des Enfants - Toulouse

    RECRUITING

    Toulouse, 31300, France

  • IRCCS Ospedale Pediatrico Bambino Gesù

    RECRUITING

    Rome, 00165, Italy

  • Ippokratio Thessaloniki General Hospital

    RECRUITING

    Thessaloniki, Thessaloniki, Greece

  • King Abdulaziz Medical City

    RECRUITING

    Riyadh, 14611, Saudi Arabia

  • King Faisal Specialist Hospital & Research Centre

    RECRUITING

    Riyadh, 12713, Saudi Arabia

  • King Saud University

    RECRUITING

    Riyadh, 11451, Saudi Arabia

  • Miller School of Medicine, University of Miami

    RECRUITING

    Miami, Florida, 33124, United States

  • Monash Medical Centre Clayton

    RECRUITING

    Clayton, 3168, Australia

  • Northwell Health Cohen Children's Medical Center

    NOT_YET_RECRUITING

    New York, New York, 11042, United States

  • Pan and Aglaia Kyriakou Children's Hospital

    RECRUITING

    Athens, Greece

  • Schneider Children's Medical Center of Israel

    RECRUITING

    Petach Tikvah, 4920235, Israel

  • Shaare Zedek Medical Center

    RECRUITING

    Jerusalem, 9103102, Israel

  • Sidra Medicine

    NOT_YET_RECRUITING

    Doha, Qatar

  • Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara

    RECRUITING

    Timișoara, 300011, Romania

  • Texas Tech University Health Sciences Center Amarillo

    TERMINATED

    Amarillo, Texas, 79106, United States

  • The Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • The Royal Children's Hospital (RCH)

    RECRUITING

    Parkville, 3052, Australia

  • UF Health Pediatric Multispecialty Center Site

    TERMINATED

    Jacksonville, Florida, 32207, United States

  • UZ Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • Unidade Local de Saude de Santo Antonio, E.P.E.

    RECRUITING

    Porto, 4050-342, Portugal

  • Universitair Ziekenhuis Gent

    RECRUITING

    Ghent, 9000, Belgium

  • University of Illinois College of Medicine

    RECRUITING

    Peoria, Illinois, 61605, United States

  • Uniwersytecki Szpital Kliniczny we Wrocławiu

    NOT_YET_RECRUITING

    Wroclaw, 50-369, Poland

  • Vanderbilt Children's Hospital Neurology

    RECRUITING

    Nashville, Tennessee, 37232, United States

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Other studies related to the condition(s) this trial covers.