Actively Recruiting
Patiromer for Treatment of Hyperkalaemia in Children Under 12 Years of Age
Led by Vifor Pharma, Inc. · Updated on 2026-03-13
32
Participants Needed
37
Research Sites
295 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A study to evaluate the pharmacodynamic effects, safety, and tolerability of patiromer in children under 12 years of age with hyperkalaemia.
CONDITIONS
Official Title
Patiromer for Treatment of Hyperkalaemia in Children Under 12 Years of Age
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pediatric participants under 12 years old with hyperkalaemia at screening
- Child will not turn 12 during the 28-day treatment period
- Able to receive regular feeding and medication, including via feeding tubes
- Two consecutive potassium tests above the age-appropriate upper limit of normal at screening
- Stable doses of RAAS inhibitors, beta blockers, fludrocortisone, or diuretics for at least 14 days before screening if taking these
- Parent or legal representative available to support follow-up and medication administration
- Females of childbearing potential must be non-lactating, test negative for pregnancy, and use effective contraception before and during the study
- Stable peritoneal dialysis treatment for at least 4 weeks (or 8 weeks if newly started) before screening
You will not qualify if you...
- Infants born before 37 weeks gestation cannot join Cohort 3
- Not suitable for blood withdrawal due to anemia or low body weight
- Maintenance hemodialysis, renal artery stenosis, acute kidney injury or recent acute renal insufficiency within 3 months
- Severe gastrointestinal disorders or surgeries affecting drug transit, unless feeding tubes are used
- Active cancer, ongoing cancer treatment, or cancer history within 2 years (except non-melanoma skin cancer)
- Scheduled kidney transplant within 28 days after Day 1
- History of sudden infant death in a sibling for participants under 2 years
- Unstable doses or anticipated changes of certain medications like digoxin, bronchodilators, theophylline, heparins, tacrolimus, mycophenolate mofetil, cyclosporine, trimethoprim, or cotrimoxazole
- Use of investigational products for unapproved indications within 30 days or 5 half-lives
- Known allergy to patiromer or its components
- Breastfed children if mother has suspected substance misuse or is taking potassium supplements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 37 locations
1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Not Yet Recruiting
2
UF Health Pediatric Multispecialty Center Site
Jacksonville, Florida, United States, 32207
Terminated
3
Miller School of Medicine, University of Miami
Miami, Florida, United States, 33124
Actively Recruiting
4
Arnold Palmer Hospital for Children
Orlando, Florida, United States, 32806
Actively Recruiting
5
Augusta University - Children's Hospital of Georgia
Augusta, Georgia, United States, 30912
Actively Recruiting
6
University of Illinois College of Medicine
Peoria, Illinois, United States, 61605
Actively Recruiting
7
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
8
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Actively Recruiting
9
Duke University Hospital & Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
10
Duke University Hospital
Durham, North Carolina, United States, 27710
Actively Recruiting
11
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
12
Vanderbilt Children's Hospital Neurology
Nashville, Tennessee, United States, 37232
Actively Recruiting
13
Texas Tech University Health Sciences Center Amarillo
Amarillo, Texas, United States, 79106
Terminated
14
Monash Medical Centre Clayton
Clayton, Australia, 3168
Actively Recruiting
15
The Royal Children's Hospital (RCH)
Parkville, Australia, 3052
Actively Recruiting
16
Children's Hospital Westmead Centre for Kidney Research
Westmead, Australia, 2145
Not Yet Recruiting
17
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
Actively Recruiting
18
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
19
Helsingin Yliopistollinen Keskussairaala Uusi Lastensairaala
Helsinki, Finland, 00290
Not Yet Recruiting
20
CHRU Montpellier - Arnaud de Villeneuve
Montpellier, France, 34090
Actively Recruiting
21
Assistance Publique-Hopitaux de Paris Robert-Debre
Paris, France, 75019
Actively Recruiting
22
Hôpital des Enfants - Toulouse
Toulouse, France, 31300
Actively Recruiting
23
Ippokratio Thessaloniki General Hospital
Thessaloniki, Thessaloniki, Greece
Actively Recruiting
24
Pan and Aglaia Kyriakou Children's Hospital
Athens, Greece
Actively Recruiting
25
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
Actively Recruiting
26
Schneider Children's Medical Center of Israel
Petach Tikvah, Israel, 4920235
Actively Recruiting
27
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy, 20122
Actively Recruiting
28
IRCCS Ospedale Pediatrico Bambino Gesù
Rome, Italy, 00165
Actively Recruiting
29
Helse Bergen HF Haukeland Universitetssjukehus
Bergen, Norway, 5009
Not Yet Recruiting
30
Uniwersytecki Szpital Kliniczny we Wrocławiu
Wroclaw, Poland, 50-369
Not Yet Recruiting
31
Unidade Local de Saude de Santo Antonio, E.P.E.
Porto, Portugal, 4050-342
Not Yet Recruiting
32
Sidra Medicine
Doha, Qatar
Not Yet Recruiting
33
Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara
Timișoara, Romania, 300011
Actively Recruiting
34
King Saud University
Riyadh, Saudi Arabia, 11451
Not Yet Recruiting
35
King Faisal Specialist Hospital & Research Centre
Riyadh, Saudi Arabia, 12713
Actively Recruiting
36
King Abdulaziz Medical City
Riyadh, Saudi Arabia, 14611
Not Yet Recruiting
37
Al Jalila Children's Hospital
Dubai, United Arab Emirates
Actively Recruiting
Research Team
E
EMERALD-2 Clinical Study Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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