Patiromer for Treatment of Hyperkalaemia in Children Under 12 Years of Age

Recruiting now · Phase 2

Conditions studied: Hyperkalemia

In brief

A study to evaluate the pharmacodynamic effects, safety, and tolerability of patiromer in children under 12 years of age with hyperkalaemia.

Key facts

Study ID

NCT05766839

Run by

Vifor Pharma, Inc.

People needed

32

Starts

2025-04-06

Expected to finish

2030-12-01

Last updated by the study team

2026-07-28

Who can join

Age: any, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:
• There is suspicion of current alcohol or substance misuse/abuse in breastfeeding mother.
• The breastfeeding mother is taking potassium supplements
• Other protocol defined Inclusion/Exclusion criteria may apply.

Where it is running

• Children's Hospital Colorado — Aurora, Colorado, United States (enrolling)
• Unidade Local de Saude de Santo Antonio, E.P.E. — Porto, Portugal (enrolling)
• Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara — Timișoara, Romania (enrolling)
• King Saud University — Riyadh, Saudi Arabia (enrolling)
• King Faisal Specialist Hospital & Research Centre — Riyadh, Saudi Arabia (enrolling)
• King Abdulaziz Medical City — Riyadh, Saudi Arabia (enrolling)
• Al Jalila Children's Hospital — Dubai, United Arab Emirates (enrolling)
• Miller School of Medicine, University of Miami — Miami, Florida, United States (enrolling)
• Arnold Palmer Hospital for Children — Orlando, Florida, United States (enrolling)
• Augusta University - Children's Hospital of Georgia — Augusta, Georgia, United States (enrolling)
• University of Illinois College of Medicine — Peoria, Illinois, United States (enrolling)
• Boston Children's Hospital — Boston, Massachusetts, United States (enrolling)
• Children's Mercy Hospitals and Clinics — Kansas City, Missouri, United States (enrolling)
• Duke University Hospital — Durham, North Carolina, United States (enrolling)
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• Vanderbilt Children's Hospital Neurology — Nashville, Tennessee, United States (enrolling)
• Monash Medical Centre Clayton — Clayton, Australia (enrolling)
• The Royal Children's Hospital (RCH) — Parkville, Australia (enrolling)
• Children's Hospital Westmead Centre for Kidney Research — Westmead, Australia (enrolling)
• Universitair Ziekenhuis Gent — Ghent, Belgium (enrolling)
• UZ Leuven — Leuven, Belgium (enrolling)
• CHRU Montpellier - Arnaud de Villeneuve — Montpellier, France (enrolling)
• Assistance Publique-Hopitaux de Paris Robert-Debre — Paris, France (enrolling)
• Hôpital des Enfants - Toulouse — Toulouse, France (enrolling)
• Ippokratio Thessaloniki General Hospital — Thessaloniki, Thessaloniki, Greece (enrolling)

Full record on ClinicalTrials.gov

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