[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100498175":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":402,"collaborators":19,"id":404,"slug":405,"hasResults":406,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":19,"eligibilityCriteria":410,"healthyVolunteers":406,"sex":411,"minAge":412,"maxAge":413,"enrollmentInfo":414,"targetDuration":19,"studyType":417,"phases":418,"briefSummary":420,"conditions":421,"keywords":19,"overallStatus":34,"whyStopped":19,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":432},{"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",[32,46,57,66,75,85,95,105,115,125,130,140,150,160,171,180,189,203,212,224,238,249,258,270,280,291,295,306,315,326,337,348,358,369,380,386,392],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":19},"Children's Hospital Colorado","RECRUITING","Aurora","Colorado","80045","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-104.83192,39.72943,{"lat":44,"lon":43},{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":38,"countryCode":39,"cosmosGeoPoint":52,"geoPoint":56,"contacts":19},"UF Health Pediatric Multispecialty Center Site","TERMINATED","Jacksonville","Florida","32207",{"type":41,"coordinates":53},[54,55],-81.65565,30.33218,{"lat":55,"lon":54},{"facility":58,"status":34,"city":59,"state":50,"zip":60,"country":38,"countryCode":39,"cosmosGeoPoint":61,"geoPoint":65,"contacts":19},"Miller School of Medicine, University of Miami","Miami","33124",{"type":41,"coordinates":62},[63,64],-80.19366,25.77427,{"lat":64,"lon":63},{"facility":67,"status":34,"city":68,"state":50,"zip":69,"country":38,"countryCode":39,"cosmosGeoPoint":70,"geoPoint":74,"contacts":19},"Arnold Palmer Hospital for Children","Orlando","32806",{"type":41,"coordinates":71},[72,73],-81.37924,28.53834,{"lat":73,"lon":72},{"facility":76,"status":34,"city":77,"state":78,"zip":79,"country":38,"countryCode":39,"cosmosGeoPoint":80,"geoPoint":84,"contacts":19},"Augusta University - Children's Hospital of Georgia","Augusta","Georgia","30912",{"type":41,"coordinates":81},[82,83],-81.97484,33.47097,{"lat":83,"lon":82},{"facility":86,"status":34,"city":87,"state":88,"zip":89,"country":38,"countryCode":39,"cosmosGeoPoint":90,"geoPoint":94,"contacts":19},"University of Illinois College of Medicine","Peoria","Illinois","61605",{"type":41,"coordinates":91},[92,93],-89.58899,40.69365,{"lat":93,"lon":92},{"facility":96,"status":34,"city":97,"state":98,"zip":99,"country":38,"countryCode":39,"cosmosGeoPoint":100,"geoPoint":104,"contacts":19},"Boston Children's Hospital","Boston","Massachusetts","02115",{"type":41,"coordinates":101},[102,103],-71.05977,42.35843,{"lat":103,"lon":102},{"facility":106,"status":34,"city":107,"state":108,"zip":109,"country":38,"countryCode":39,"cosmosGeoPoint":110,"geoPoint":114,"contacts":19},"Children's Mercy Hospitals and Clinics","Kansas City","Missouri","64108",{"type":41,"coordinates":111},[112,113],-94.57857,39.09973,{"lat":113,"lon":112},{"facility":116,"status":34,"city":117,"state":118,"zip":119,"country":38,"countryCode":39,"cosmosGeoPoint":120,"geoPoint":124,"contacts":19},"Duke University Hospital & Medical Center","Durham","North Carolina","27710",{"type":41,"coordinates":121},[122,123],-78.89862,35.99403,{"lat":123,"lon":122},{"facility":126,"status":34,"city":117,"state":118,"zip":119,"country":38,"countryCode":39,"cosmosGeoPoint":127,"geoPoint":129,"contacts":19},"Duke University Hospital",{"type":41,"coordinates":128},[122,123],{"lat":123,"lon":122},{"facility":131,"status":34,"city":132,"state":133,"zip":134,"country":38,"countryCode":39,"cosmosGeoPoint":135,"geoPoint":139,"contacts":19},"The Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19104",{"type":41,"coordinates":136},[137,138],-75.16362,39.95238,{"lat":138,"lon":137},{"facility":141,"status":34,"city":142,"state":143,"zip":144,"country":38,"countryCode":39,"cosmosGeoPoint":145,"geoPoint":149,"contacts":19},"Vanderbilt Children's Hospital Neurology","Nashville","Tennessee","37232",{"type":41,"coordinates":146},[147,148],-86.78444,36.16589,{"lat":148,"lon":147},{"facility":151,"status":48,"city":152,"state":153,"zip":154,"country":38,"countryCode":39,"cosmosGeoPoint":155,"geoPoint":159,"contacts":19},"Texas Tech University Health Sciences Center Amarillo","Amarillo","Texas","79106",{"type":41,"coordinates":156},[157,158],-101.8313,35.222,{"lat":158,"lon":157},{"facility":161,"status":34,"city":162,"state":19,"zip":163,"country":164,"countryCode":165,"cosmosGeoPoint":166,"geoPoint":170,"contacts":19},"Monash Medical Centre Clayton","Clayton","3168","Australia","AU",{"type":41,"coordinates":167},[168,169],145.11667,-37.91667,{"lat":169,"lon":168},{"facility":172,"status":34,"city":173,"state":19,"zip":174,"country":164,"countryCode":165,"cosmosGeoPoint":175,"geoPoint":179,"contacts":19},"The Royal Children's Hospital (RCH)","Parkville","3052",{"type":41,"coordinates":176},[177,178],144.95,-37.78333,{"lat":178,"lon":177},{"facility":181,"status":34,"city":182,"state":19,"zip":183,"country":164,"countryCode":165,"cosmosGeoPoint":184,"geoPoint":188,"contacts":19},"Children's Hospital Westmead Centre for Kidney Research","Westmead","2145",{"type":41,"coordinates":185},[186,187],150.98768,-33.80383,{"lat":187,"lon":186},{"facility":190,"status":34,"city":191,"state":19,"zip":192,"country":193,"countryCode":194,"cosmosGeoPoint":195,"geoPoint":199,"contacts":200},"Universitair Ziekenhuis Gent","Ghent","9000","Belgium","BE",{"type":41,"coordinates":196},[197,198],3.71667,51.05,{"lat":198,"lon":197},[201],{"name":202,"role":28,"phone":19,"phoneExt":19,"email":19},"Central Contract",{"facility":204,"status":34,"city":205,"state":19,"zip":206,"country":193,"countryCode":194,"cosmosGeoPoint":207,"geoPoint":211,"contacts":19},"UZ Leuven","Leuven","3000",{"type":41,"coordinates":208},[209,210],4.70093,50.87959,{"lat":210,"lon":209},{"facility":213,"status":214,"city":215,"state":19,"zip":216,"country":217,"countryCode":218,"cosmosGeoPoint":219,"geoPoint":223,"contacts":19},"Helsingin Yliopistollinen Keskussairaala Uusi Lastensairaala","NOT_YET_RECRUITING","Helsinki","00290","Finland","FI",{"type":41,"coordinates":220},[221,222],24.93545,60.16952,{"lat":222,"lon":221},{"facility":225,"status":34,"city":226,"state":19,"zip":227,"country":228,"countryCode":229,"cosmosGeoPoint":230,"geoPoint":234,"contacts":235},"CHRU Montpellier - Arnaud de Villeneuve","Montpellier","34090","France","FR",{"type":41,"coordinates":231},[232,233],3.87635,43.61093,{"lat":233,"lon":232},[236],{"name":237,"role":28,"phone":19,"phoneExt":19,"email":19},"Central Contact",{"facility":239,"status":34,"city":240,"state":19,"zip":241,"country":228,"countryCode":229,"cosmosGeoPoint":242,"geoPoint":246,"contacts":247},"Assistance Publique-Hopitaux de Paris Robert-Debre","Paris","75019",{"type":41,"coordinates":243},[244,245],2.3488,48.85341,{"lat":245,"lon":244},[248],{"name":237,"role":28,"phone":19,"phoneExt":19,"email":19},{"facility":250,"status":34,"city":251,"state":19,"zip":252,"country":228,"countryCode":229,"cosmosGeoPoint":253,"geoPoint":257,"contacts":19},"Hôpital des Enfants - Toulouse","Toulouse","31300",{"type":41,"coordinates":254},[255,256],1.44367,43.60426,{"lat":256,"lon":255},{"facility":259,"status":34,"city":260,"state":260,"zip":19,"country":261,"countryCode":262,"cosmosGeoPoint":263,"geoPoint":267,"contacts":268},"Ippokratio Thessaloniki General Hospital","Thessaloniki","Greece","GR",{"type":41,"coordinates":264},[265,266],22.93493,40.64072,{"lat":266,"lon":265},[269],{"name":202,"role":28,"phone":19,"phoneExt":19,"email":19},{"facility":271,"status":34,"city":272,"state":19,"zip":19,"country":261,"countryCode":262,"cosmosGeoPoint":273,"geoPoint":277,"contacts":278},"Pan and Aglaia Kyriakou Children's Hospital","Athens",{"type":41,"coordinates":274},[275,276],23.72784,37.98376,{"lat":276,"lon":275},[279],{"name":237,"role":28,"phone":19,"phoneExt":19,"email":19},{"facility":281,"status":34,"city":282,"state":19,"zip":283,"country":284,"countryCode":285,"cosmosGeoPoint":286,"geoPoint":290,"contacts":19},"Shaare Zedek Medical Center","Jerusalem","9103102","Israel","IL",{"type":41,"coordinates":287},[288,289],35.21633,31.76904,{"lat":289,"lon":288},{"facility":292,"status":34,"city":293,"state":19,"zip":294,"country":284,"countryCode":285,"cosmosGeoPoint":19,"geoPoint":19,"contacts":19},"Schneider Children's Medical Center of Israel","Petach Tikvah","4920235",{"facility":296,"status":34,"city":297,"state":19,"zip":298,"country":299,"countryCode":300,"cosmosGeoPoint":301,"geoPoint":305,"contacts":19},"Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico","Milan","20122","Italy","IT",{"type":41,"coordinates":302},[303,304],9.18951,45.46427,{"lat":304,"lon":303},{"facility":307,"status":34,"city":308,"state":19,"zip":309,"country":299,"countryCode":300,"cosmosGeoPoint":310,"geoPoint":314,"contacts":19},"IRCCS Ospedale Pediatrico Bambino Gesù","Rome","00165",{"type":41,"coordinates":311},[312,313],12.51133,41.89193,{"lat":313,"lon":312},{"facility":316,"status":34,"city":317,"state":19,"zip":318,"country":319,"countryCode":320,"cosmosGeoPoint":321,"geoPoint":325,"contacts":19},"Helse Bergen HF Haukeland Universitetssjukehus","Bergen","5009","Norway","NO",{"type":41,"coordinates":322},[323,324],5.32415,60.39299,{"lat":324,"lon":323},{"facility":327,"status":214,"city":328,"state":19,"zip":329,"country":330,"countryCode":331,"cosmosGeoPoint":332,"geoPoint":336,"contacts":19},"Uniwersytecki Szpital Kliniczny we Wrocławiu","Wroclaw","50-369","Poland","PL",{"type":41,"coordinates":333},[334,335],17.03006,51.10286,{"lat":335,"lon":334},{"facility":338,"status":34,"city":339,"state":19,"zip":340,"country":341,"countryCode":342,"cosmosGeoPoint":343,"geoPoint":347,"contacts":19},"Unidade Local de Saude de Santo Antonio, E.P.E.","Porto","4050-342","Portugal","PT",{"type":41,"coordinates":344},[345,346],-8.61097,41.1485,{"lat":346,"lon":345},{"facility":349,"status":214,"city":350,"state":19,"zip":19,"country":351,"countryCode":352,"cosmosGeoPoint":353,"geoPoint":357,"contacts":19},"Sidra Medicine","Doha","Qatar","QA",{"type":41,"coordinates":354},[355,356],51.53096,25.28545,{"lat":356,"lon":355},{"facility":359,"status":34,"city":360,"state":19,"zip":361,"country":362,"countryCode":363,"cosmosGeoPoint":364,"geoPoint":368,"contacts":19},"Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara","Timișoara","300011","Romania","RO",{"type":41,"coordinates":365},[366,367],21.22571,45.75372,{"lat":367,"lon":366},{"facility":370,"status":34,"city":371,"state":19,"zip":372,"country":373,"countryCode":374,"cosmosGeoPoint":375,"geoPoint":379,"contacts":19},"King Saud University","Riyadh","11451","Saudi Arabia","SA",{"type":41,"coordinates":376},[377,378],46.72185,24.68773,{"lat":378,"lon":377},{"facility":381,"status":34,"city":371,"state":19,"zip":382,"country":373,"countryCode":374,"cosmosGeoPoint":383,"geoPoint":385,"contacts":19},"King Faisal Specialist Hospital & Research Centre","12713",{"type":41,"coordinates":384},[377,378],{"lat":378,"lon":377},{"facility":387,"status":34,"city":371,"state":19,"zip":388,"country":373,"countryCode":374,"cosmosGeoPoint":389,"geoPoint":391,"contacts":19},"King Abdulaziz Medical City","14611",{"type":41,"coordinates":390},[377,378],{"lat":378,"lon":377},{"facility":393,"status":34,"city":394,"state":19,"zip":19,"country":395,"countryCode":396,"cosmosGeoPoint":397,"geoPoint":401,"contacts":19},"Al Jalila Children's Hospital","Dubai","United Arab Emirates","AE",{"type":41,"coordinates":398},[399,400],55.30927,25.07725,{"lat":400,"lon":399},{"type":403,"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* 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":415,"type":416},32,"ESTIMATED","INTERVENTIONAL",[419],"PHASE2","A study to evaluate the pharmacodynamic effects, safety, and tolerability of patiromer in children under 12 years of age with hyperkalaemia.",[422],"Hyperkalemia","2026-05-29",{"date":425,"type":426},"2026-06-01","ACTUAL",{"date":428,"type":426},"2025-04-06",{"date":430,"type":416},"2030-12-01",{"name":23,"class":6},37]