[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100498175":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":387,"collaborators":19,"id":389,"slug":19,"hasResults":390,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":19,"eligibilityCriteria":394,"healthyVolunteers":390,"sex":395,"minAge":396,"maxAge":397,"enrollmentInfo":398,"targetDuration":19,"studyType":401,"phases":402,"briefSummary":404,"conditions":405,"keywords":19,"overallStatus":34,"whyStopped":19,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":416},{"fullName":5,"class":6},"Vifor Pharma","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patiromer","EXPERIMENTAL","4-week pharmacodynamic \u002Fdose-ranging period\n\nCohort 1: 6 to less than(\\<)12 years of age\n\nCohort 2: 2 to \\<6 years of age\n\nCohort 3: 0 to \\<2 years of age; In Cohort 3, a minimum of 3 study participants will be assessed in the subgroup of 0 to \\<6 months and another 3 study participants in the subgroup 6 to \\<24 months of age.",[13],"Drug: Patiromer",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Patiromer will be given once daily; In Cohort 3, depending on the dose and the study participant's age, the total daily dose might be split",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Julian Platon, MD, PhD","Vifor Pharma, Inc.","STUDY_DIRECTOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"EMERALD-2 Clinical Study Team","CONTACT","+41 58 851 80 00","clinicaltrials@cslbehring.com",[32,45,56,65,74,84,94,104,114,124,129,139,149,159,169,178,187,200,209,220,233,244,253,264,274,284,288,298,307,317,327,337,346,356,366,372,378],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":19},"Children's Hospital Colorado","RECRUITING","Aurora","Colorado","80045","United States",{"type":40,"coordinates":41},"Point",[42,43],-104.83192,39.72943,{"lat":43,"lon":42},{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":38,"cosmosGeoPoint":51,"geoPoint":55,"contacts":19},"UF Health Pediatric Multispecialty Center Site","TERMINATED","Jacksonville","Florida","32207",{"type":40,"coordinates":52},[53,54],-81.65565,30.33218,{"lat":54,"lon":53},{"facility":57,"status":34,"city":58,"state":49,"zip":59,"country":38,"cosmosGeoPoint":60,"geoPoint":64,"contacts":19},"Miller School of Medicine, University of Miami","Miami","33124",{"type":40,"coordinates":61},[62,63],-80.19366,25.77427,{"lat":63,"lon":62},{"facility":66,"status":34,"city":67,"state":49,"zip":68,"country":38,"cosmosGeoPoint":69,"geoPoint":73,"contacts":19},"Arnold Palmer Hospital for Children","Orlando","32806",{"type":40,"coordinates":70},[71,72],-81.37924,28.53834,{"lat":72,"lon":71},{"facility":75,"status":34,"city":76,"state":77,"zip":78,"country":38,"cosmosGeoPoint":79,"geoPoint":83,"contacts":19},"Augusta University - Children's Hospital of Georgia","Augusta","Georgia","30912",{"type":40,"coordinates":80},[81,82],-81.97484,33.47097,{"lat":82,"lon":81},{"facility":85,"status":34,"city":86,"state":87,"zip":88,"country":38,"cosmosGeoPoint":89,"geoPoint":93,"contacts":19},"University of Illinois College of Medicine","Peoria","Illinois","61605",{"type":40,"coordinates":90},[91,92],-89.58899,40.69365,{"lat":92,"lon":91},{"facility":95,"status":34,"city":96,"state":97,"zip":98,"country":38,"cosmosGeoPoint":99,"geoPoint":103,"contacts":19},"Boston Children's Hospital","Boston","Massachusetts","02115",{"type":40,"coordinates":100},[101,102],-71.05977,42.35843,{"lat":102,"lon":101},{"facility":105,"status":34,"city":106,"state":107,"zip":108,"country":38,"cosmosGeoPoint":109,"geoPoint":113,"contacts":19},"Children's Mercy Hospitals and Clinics","Kansas City","Missouri","64108",{"type":40,"coordinates":110},[111,112],-94.57857,39.09973,{"lat":112,"lon":111},{"facility":115,"status":34,"city":116,"state":117,"zip":118,"country":38,"cosmosGeoPoint":119,"geoPoint":123,"contacts":19},"Duke University Hospital & Medical Center","Durham","North Carolina","27710",{"type":40,"coordinates":120},[121,122],-78.89862,35.99403,{"lat":122,"lon":121},{"facility":125,"status":34,"city":116,"state":117,"zip":118,"country":38,"cosmosGeoPoint":126,"geoPoint":128,"contacts":19},"Duke University Hospital",{"type":40,"coordinates":127},[121,122],{"lat":122,"lon":121},{"facility":130,"status":34,"city":131,"state":132,"zip":133,"country":38,"cosmosGeoPoint":134,"geoPoint":138,"contacts":19},"The Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19104",{"type":40,"coordinates":135},[136,137],-75.16362,39.95238,{"lat":137,"lon":136},{"facility":140,"status":34,"city":141,"state":142,"zip":143,"country":38,"cosmosGeoPoint":144,"geoPoint":148,"contacts":19},"Vanderbilt Children's Hospital Neurology","Nashville","Tennessee","37232",{"type":40,"coordinates":145},[146,147],-86.78444,36.16589,{"lat":147,"lon":146},{"facility":150,"status":47,"city":151,"state":152,"zip":153,"country":38,"cosmosGeoPoint":154,"geoPoint":158,"contacts":19},"Texas Tech University Health Sciences Center Amarillo","Amarillo","Texas","79106",{"type":40,"coordinates":155},[156,157],-101.8313,35.222,{"lat":157,"lon":156},{"facility":160,"status":34,"city":161,"state":19,"zip":162,"country":163,"cosmosGeoPoint":164,"geoPoint":168,"contacts":19},"Monash Medical Centre Clayton","Clayton","3168","Australia",{"type":40,"coordinates":165},[166,167],145.11667,-37.91667,{"lat":167,"lon":166},{"facility":170,"status":34,"city":171,"state":19,"zip":172,"country":163,"cosmosGeoPoint":173,"geoPoint":177,"contacts":19},"The Royal Children's Hospital (RCH)","Parkville","3052",{"type":40,"coordinates":174},[175,176],144.95,-37.78333,{"lat":176,"lon":175},{"facility":179,"status":34,"city":180,"state":19,"zip":181,"country":163,"cosmosGeoPoint":182,"geoPoint":186,"contacts":19},"Children's Hospital Westmead Centre for Kidney Research","Westmead","2145",{"type":40,"coordinates":183},[184,185],150.98768,-33.80383,{"lat":185,"lon":184},{"facility":188,"status":34,"city":189,"state":19,"zip":190,"country":191,"cosmosGeoPoint":192,"geoPoint":196,"contacts":197},"Universitair Ziekenhuis Gent","Ghent","9000","Belgium",{"type":40,"coordinates":193},[194,195],3.71667,51.05,{"lat":195,"lon":194},[198],{"name":199,"role":28,"phone":19,"phoneExt":19,"email":19},"Central Contract",{"facility":201,"status":34,"city":202,"state":19,"zip":203,"country":191,"cosmosGeoPoint":204,"geoPoint":208,"contacts":19},"UZ Leuven","Leuven","3000",{"type":40,"coordinates":205},[206,207],4.70093,50.87959,{"lat":207,"lon":206},{"facility":210,"status":211,"city":212,"state":19,"zip":213,"country":214,"cosmosGeoPoint":215,"geoPoint":219,"contacts":19},"Helsingin Yliopistollinen Keskussairaala Uusi Lastensairaala","NOT_YET_RECRUITING","Helsinki","00290","Finland",{"type":40,"coordinates":216},[217,218],24.93545,60.16952,{"lat":218,"lon":217},{"facility":221,"status":34,"city":222,"state":19,"zip":223,"country":224,"cosmosGeoPoint":225,"geoPoint":229,"contacts":230},"CHRU Montpellier - Arnaud de Villeneuve","Montpellier","34090","France",{"type":40,"coordinates":226},[227,228],3.87635,43.61093,{"lat":228,"lon":227},[231],{"name":232,"role":28,"phone":19,"phoneExt":19,"email":19},"Central Contact",{"facility":234,"status":34,"city":235,"state":19,"zip":236,"country":224,"cosmosGeoPoint":237,"geoPoint":241,"contacts":242},"Assistance Publique-Hopitaux de Paris Robert-Debre","Paris","75019",{"type":40,"coordinates":238},[239,240],2.3488,48.85341,{"lat":240,"lon":239},[243],{"name":232,"role":28,"phone":19,"phoneExt":19,"email":19},{"facility":245,"status":34,"city":246,"state":19,"zip":247,"country":224,"cosmosGeoPoint":248,"geoPoint":252,"contacts":19},"Hôpital des Enfants - Toulouse","Toulouse","31300",{"type":40,"coordinates":249},[250,251],1.44367,43.60426,{"lat":251,"lon":250},{"facility":254,"status":34,"city":255,"state":255,"zip":19,"country":256,"cosmosGeoPoint":257,"geoPoint":261,"contacts":262},"Ippokratio Thessaloniki General Hospital","Thessaloniki","Greece",{"type":40,"coordinates":258},[259,260],22.93493,40.64072,{"lat":260,"lon":259},[263],{"name":199,"role":28,"phone":19,"phoneExt":19,"email":19},{"facility":265,"status":34,"city":266,"state":19,"zip":19,"country":256,"cosmosGeoPoint":267,"geoPoint":271,"contacts":272},"Pan and Aglaia Kyriakou Children's Hospital","Athens",{"type":40,"coordinates":268},[269,270],23.72784,37.98376,{"lat":270,"lon":269},[273],{"name":232,"role":28,"phone":19,"phoneExt":19,"email":19},{"facility":275,"status":34,"city":276,"state":19,"zip":277,"country":278,"cosmosGeoPoint":279,"geoPoint":283,"contacts":19},"Shaare Zedek Medical Center","Jerusalem","9103102","Israel",{"type":40,"coordinates":280},[281,282],35.21633,31.76904,{"lat":282,"lon":281},{"facility":285,"status":34,"city":286,"state":19,"zip":287,"country":278,"cosmosGeoPoint":19,"geoPoint":19,"contacts":19},"Schneider Children's Medical Center of Israel","Petach Tikvah","4920235",{"facility":289,"status":34,"city":290,"state":19,"zip":291,"country":292,"cosmosGeoPoint":293,"geoPoint":297,"contacts":19},"Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico","Milan","20122","Italy",{"type":40,"coordinates":294},[295,296],9.18951,45.46427,{"lat":296,"lon":295},{"facility":299,"status":34,"city":300,"state":19,"zip":301,"country":292,"cosmosGeoPoint":302,"geoPoint":306,"contacts":19},"IRCCS Ospedale Pediatrico Bambino Gesù","Rome","00165",{"type":40,"coordinates":303},[304,305],12.51133,41.89193,{"lat":305,"lon":304},{"facility":308,"status":34,"city":309,"state":19,"zip":310,"country":311,"cosmosGeoPoint":312,"geoPoint":316,"contacts":19},"Helse Bergen HF Haukeland Universitetssjukehus","Bergen","5009","Norway",{"type":40,"coordinates":313},[314,315],5.32415,60.39299,{"lat":315,"lon":314},{"facility":318,"status":211,"city":319,"state":19,"zip":320,"country":321,"cosmosGeoPoint":322,"geoPoint":326,"contacts":19},"Uniwersytecki Szpital Kliniczny we Wrocławiu","Wroclaw","50-369","Poland",{"type":40,"coordinates":323},[324,325],17.03006,51.10286,{"lat":325,"lon":324},{"facility":328,"status":34,"city":329,"state":19,"zip":330,"country":331,"cosmosGeoPoint":332,"geoPoint":336,"contacts":19},"Unidade Local de Saude de Santo Antonio, E.P.E.","Porto","4050-342","Portugal",{"type":40,"coordinates":333},[334,335],-8.61097,41.1485,{"lat":335,"lon":334},{"facility":338,"status":211,"city":339,"state":19,"zip":19,"country":340,"cosmosGeoPoint":341,"geoPoint":345,"contacts":19},"Sidra Medicine","Doha","Qatar",{"type":40,"coordinates":342},[343,344],51.53096,25.28545,{"lat":344,"lon":343},{"facility":347,"status":34,"city":348,"state":19,"zip":349,"country":350,"cosmosGeoPoint":351,"geoPoint":355,"contacts":19},"Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara","Timișoara","300011","Romania",{"type":40,"coordinates":352},[353,354],21.22571,45.75372,{"lat":354,"lon":353},{"facility":357,"status":34,"city":358,"state":19,"zip":359,"country":360,"cosmosGeoPoint":361,"geoPoint":365,"contacts":19},"King Saud University","Riyadh","11451","Saudi Arabia",{"type":40,"coordinates":362},[363,364],46.72185,24.68773,{"lat":364,"lon":363},{"facility":367,"status":34,"city":358,"state":19,"zip":368,"country":360,"cosmosGeoPoint":369,"geoPoint":371,"contacts":19},"King Faisal Specialist Hospital & Research Centre","12713",{"type":40,"coordinates":370},[363,364],{"lat":364,"lon":363},{"facility":373,"status":34,"city":358,"state":19,"zip":374,"country":360,"cosmosGeoPoint":375,"geoPoint":377,"contacts":19},"King Abdulaziz Medical City","14611",{"type":40,"coordinates":376},[363,364],{"lat":364,"lon":363},{"facility":379,"status":34,"city":380,"state":19,"zip":19,"country":381,"cosmosGeoPoint":382,"geoPoint":386,"contacts":19},"Al Jalila Children's Hospital","Dubai","United Arab Emirates",{"type":40,"coordinates":383},[384,385],55.30927,25.07725,{"lat":385,"lon":384},{"type":388,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"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":399,"type":400},32,"ESTIMATED","INTERVENTIONAL",[403],"PHASE2","A study to evaluate the pharmacodynamic effects, safety, and tolerability of patiromer in children under 12 years of age with hyperkalaemia.",[406],"Hyperkalemia","2026-05-29",{"date":409,"type":410},"2026-06-01","ACTUAL",{"date":412,"type":410},"2025-04-06",{"date":414,"type":400},"2030-12-01",{"name":23,"class":6},37]