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City","14611",{"type":41,"coordinates":394},[381,382],{"lat":382,"lon":381},{"facility":397,"status":34,"city":398,"state":19,"zip":19,"country":399,"countryCode":400,"cosmosGeoPoint":401,"geoPoint":405,"contacts":19},"Al Jalila Children's Hospital","Dubai","United Arab Emirates","AE",{"type":41,"coordinates":402},[403,404],55.30927,25.07725,{"lat":404,"lon":403},{"type":407,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100498175","phase-2-patiromer-for-treatment-of-hyperkalaemia-in-children-under-12-years-of-age-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* 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* 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\n  1. There is suspicion of current alcohol or substance misuse\u002Fabuse in breastfeeding mother.\n  2. The breastfeeding mother is taking potassium supplements\n* Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","0 Years","11 Years",{"count":419,"type":420},32,"ESTIMATED","INTERVENTIONAL",[423],"PHASE2","A study to evaluate the pharmacodynamic effects, safety, and tolerability of patiromer in children under 12 years of age with hyperkalaemia.",[426],"Hyperkalemia","2026-07-27",{"date":429,"type":430},"2026-07-28","ACTUAL",{"date":432,"type":430},"2025-04-06",{"date":434,"type":420},"2030-12-01",{"name":23,"class":6},37]