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E.P.E.","Porto","4050-342","Portugal","PT",{"type":110,"coordinates":413},[414,415],-8.61097,41.1485,{"lat":415,"lon":414},{"facility":418,"status":283,"city":419,"state":18,"zip":18,"country":420,"countryCode":421,"cosmosGeoPoint":422,"geoPoint":426,"contacts":18},"Sidra Medicine","Doha","Qatar","QA",{"type":110,"coordinates":423},[424,425],51.53096,25.28545,{"lat":425,"lon":424},{"facility":428,"status":103,"city":429,"state":18,"zip":430,"country":431,"countryCode":432,"cosmosGeoPoint":433,"geoPoint":437,"contacts":18},"Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara","Timișoara","300011","Romania","RO",{"type":110,"coordinates":434},[435,436],21.22571,45.75372,{"lat":436,"lon":435},{"facility":439,"status":103,"city":440,"state":18,"zip":441,"country":442,"countryCode":443,"cosmosGeoPoint":444,"geoPoint":448,"contacts":18},"King Saud University","Riyadh","11451","Saudi Arabia","SA",{"type":110,"coordinates":445},[446,447],46.72185,24.68773,{"lat":447,"lon":446},{"facility":450,"status":103,"city":440,"state":18,"zip":451,"country":442,"countryCode":443,"cosmosGeoPoint":452,"geoPoint":454,"contacts":18},"King Faisal Specialist Hospital & Research Centre","12713",{"type":110,"coordinates":453},[446,447],{"lat":447,"lon":446},{"facility":456,"status":103,"city":440,"state":18,"zip":457,"country":442,"countryCode":443,"cosmosGeoPoint":458,"geoPoint":460,"contacts":18},"King Abdulaziz Medical City","14611",{"type":110,"coordinates":459},[446,447],{"lat":447,"lon":446},{"facility":462,"status":103,"city":463,"state":18,"zip":18,"country":464,"countryCode":465,"cosmosGeoPoint":466,"geoPoint":470,"contacts":18},"Al Jalila Children's Hospital","Dubai","United Arab Emirates","AE",{"type":110,"coordinates":467},[468,469],55.30927,25.07725,{"lat":469,"lon":468},{"type":472,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100498175",false,"NCT05766839","Patiromer for Treatment of Hyperkalaemia in Children Under 12 Years of Age","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)","Inclusion Criteria:\n\n* The following inclusion criteria must be met for each participant:\n* \\- Paediatric participants (\\\u003C12 years of age) with hyperkalaemia at screening.\n* \\- Participant's age should not reach 12 years during the 28 days of the pharmacodynamic\u002Fdose-ranging period.\n* \\- Participant is able to receive regular external feeding and medication, including via tubes, i.e., percutaneous endoscopic gastrostomy (PEG) or entero-gastric feeding tube.\n* \\- At screening\u002Fbaseline, 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).\n* \\- 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.\n* \\- 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.\n* \\- 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.\n* \\- 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.\n\nExclusion Criteria:\n\n* The following criteria exclude a participant from participating in this trial:\n* \\- Preterm birth infants with \\\u003C37 weeks of gestation cannot be included in Cohort 3.\n* \\- Participants who due to their general condition, e.g., anaemia or low body weight, are not suitable to have blood volume withdrawn.\n* \\- 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.\n* \\- 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.\n* \\- Active cancer, currently on cancer treatment, or history of cancer in the past 2 years (except for non-melanoma skin cancer).\n* \\- Scheduled for kidney transplant procedure during the first 28 days after Day 1.\n* \\- History of sudden infant death in a sibling (only for participants \\\u003C2 years of age at screening).\n* \\- 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\u002F\n* dose-ranging period: digoxin, bronchodilators, theophylline, heparins (including low molecular heparins), tacrolimus, mycophenolate mofetil, cyclosporine, trimethoprim, or cotrimoxazole.\n* \\- Use of any investigational product for an unapproved indication within 30 days prior to screening or within 5 half-lives, whichever is longer.\n* \\- Known hypersensitivity to patiromer or its components.\n* \\- If the child is being breastfed:\n* a)There is suspicion of current alcohol or substance misuse\u002Fabuse in breastfeeding mother\n* b)The breastfeeding mother is taking potassium supplements\n* Other protocol defined Inclusion\u002FExclusion criteria may apply","ALL","0 Years","11 Years",{"count":483,"type":484},32,"ESTIMATED","INTERVENTIONAL",[487],"PHASE2","A study to evaluate the pharmacodynamic effects, safety, and tolerability of patiromer in children under 12 years of age with hyperkalaemia.",[490],"Hyperkalemia","2026-05-29",{"date":493,"type":494},"2026-06-01","ACTUAL",{"date":496,"type":494},"2025-04-06",{"date":498,"type":484},"2030-12-01",{"name":92,"class":6},37]