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Using patiromer to treat high potassium levels in children under 12

A 2-Part, Open-Label, Phase 2, Multiple Dose Study to Evaluate the Pharmacodynamic Effects, Safety, and Tolerability of Patiromer in Children Under 12 Years of Age With Hyperkalaemia (EMERALD2)

Phase 2 Interventional Vifor Pharma · NCT05766839

This study is testing if a medication called patiromer can safely help children under 12 with high potassium levels feel better.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment32 (estimated)
Ages0 Years to 11 Years
SexAll
SponsorVifor Pharma Industry-sponsored
Locations37 sites (Aurora, Colorado and 36 other locations)
Trial IDNCT05766839 on ClinicalTrials.gov

What this trial studies

This study evaluates the effects, safety, and tolerability of patiromer in children under 12 years of age who have hyperkalemia. It involves administering the medication and monitoring its pharmacodynamic effects over a 28-day period. Eligible participants must have elevated potassium levels confirmed by two separate tests and be able to receive regular feeding and medication. The study aims to gather data on how well patiromer works in this pediatric population.

Who should consider this trial

Good fit: Ideal candidates are pediatric patients under 12 years old diagnosed with hyperkalemia.

Not a fit: Patients who are not experiencing hyperkalemia or those over the age of 12 will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a safe and effective way to manage high potassium levels in young children.

How similar studies have performed: While there is limited data on the use of patiromer specifically in children, similar studies in adults have shown promising results.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* The following inclusion criteria must be met for each participant:
* \- 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).
* \- 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 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; accurately and reliably dispense investigational product as directed.
* \- 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.

Exclusion Criteria:

* The following criteria exclude a participant from participating in this trial:
* \- 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.
* \- 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. 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.
* \- 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).
* \- 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.
* \- If the child is being breastfed:
* a)There is suspicion of current alcohol or substance misuse/abuse in breastfeeding mother
* b)The breastfeeding mother is taking potassium supplements
* Other protocol defined Inclusion/Exclusion criteria may apply

Where this trial is running

Aurora, Colorado and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hyperkalemia
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.