[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100334387":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":440,"collaborators":30,"id":442,"slug":443,"hasResults":444,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":30,"eligibilityCriteria":448,"healthyVolunteers":444,"sex":449,"minAge":450,"maxAge":451,"enrollmentInfo":452,"targetDuration":30,"studyType":455,"phases":456,"briefSummary":458,"conditions":459,"keywords":462,"overallStatus":44,"whyStopped":30,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":468,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":476},{"fullName":5,"class":6},"Amgen","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Etelcalcetide","EXPERIMENTAL","Participants are randomized in a 5:1 ratio to receive etelcalcetide in addition to standard of care versus standard of care alone.",[13,14],"Drug: Etelcalcetide","Other: Standard of Care",{"label":16,"type":17,"description":11,"interventionNames":18},"Standard of Care","ACTIVE_COMPARATOR",[14],[20,26],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Etelcalcetide has been shown to be safe and efficacious in treating adult CKD patients with SHPT by simultaneously controlling iPTH, Ca, and phosphorus and has recently been approved for use in adult patients with SHPT treated with hemodialysis in both the United States and Europe",[9],[25],"Parsabiv",{"type":27,"name":16,"description":28,"armGroupLabels":29,"otherNames":30},"OTHER","Standard of care, which can include therapy with vitamin D sterols, Ca supplementation, and\u002For phosphate binders",[9,16],null,[32],{"name":33,"affiliation":5,"role":34},"MD","STUDY_DIRECTOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":30,"email":40},"Amgen Call 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Hospital","Kansas City","Missouri","64108",{"type":51,"coordinates":73},[74,75],-94.57857,39.09973,{"lat":75,"lon":74},{"facility":78,"status":79,"city":80,"state":80,"zip":81,"country":48,"countryCode":49,"cosmosGeoPoint":82,"geoPoint":86,"contacts":30},"Mount Sinai Kidney Center - B1 Renal Treatment","COMPLETED","New York","10029",{"type":51,"coordinates":83},[84,85],-74.00597,40.71427,{"lat":85,"lon":84},{"facility":88,"status":79,"city":89,"state":90,"zip":91,"country":48,"countryCode":49,"cosmosGeoPoint":92,"geoPoint":96,"contacts":30},"Cincinnati Childrens Hospital Medical Center","Cincinnati","Ohio","45229",{"type":51,"coordinates":93},[94,95],-84.51439,39.12711,{"lat":95,"lon":94},{"facility":98,"status":44,"city":99,"state":90,"zip":100,"country":48,"countryCode":49,"cosmosGeoPoint":101,"geoPoint":105,"contacts":30},"Cleveland Clinic Foundation","Cleveland","44195",{"type":51,"coordinates":102},[103,104],-81.69541,41.4995,{"lat":104,"lon":103},{"facility":107,"status":79,"city":108,"state":109,"zip":110,"country":48,"countryCode":49,"cosmosGeoPoint":111,"geoPoint":115,"contacts":30},"The Childrens Hospital at Oklahoma University Medical Center","Oklahoma City","Oklahoma","73104",{"type":51,"coordinates":112},[113,114],-97.51643,35.46756,{"lat":114,"lon":113},{"facility":117,"status":44,"city":118,"state":119,"zip":120,"country":48,"countryCode":49,"cosmosGeoPoint":121,"geoPoint":125,"contacts":30},"Childrens Hospital of Philadelphia","Philadelphia","Pennsylvania","19104",{"type":51,"coordinates":122},[123,124],-75.16362,39.95238,{"lat":124,"lon":123},{"facility":127,"status":58,"city":128,"state":129,"zip":130,"country":48,"countryCode":49,"cosmosGeoPoint":131,"geoPoint":135,"contacts":30},"Childrens Medical Center Dallas","Dallas","Texas","75390",{"type":51,"coordinates":132},[133,134],-96.80667,32.78306,{"lat":134,"lon":133},{"facility":137,"status":44,"city":138,"state":139,"zip":140,"country":48,"countryCode":49,"cosmosGeoPoint":141,"geoPoint":145,"contacts":30},"Primary Childrens Hospital Outpatient Services","Salt Lake City","Utah","84113",{"type":51,"coordinates":142},[143,144],-111.89105,40.76078,{"lat":144,"lon":143},{"facility":147,"status":58,"city":148,"state":149,"zip":150,"country":151,"countryCode":152,"cosmosGeoPoint":153,"geoPoint":157,"contacts":30},"Fresenius Escobar","Belen de Escobar","Buenos Aires","B1625DUG","Argentina","AR",{"type":51,"coordinates":154},[155,156],-58.79442,-34.34602,{"lat":156,"lon":155},{"facility":159,"status":44,"city":160,"state":149,"zip":161,"country":151,"countryCode":152,"cosmosGeoPoint":30,"geoPoint":30,"contacts":30},"Hospital Italiano","Cuidad Autonoma de Buenos Aires","C1199ABB",{"facility":163,"status":44,"city":164,"state":165,"zip":166,"country":151,"countryCode":152,"cosmosGeoPoint":167,"geoPoint":171,"contacts":30},"Centro Infantil Del Rinon","San Miguel de Tucumán","Tucumán Province","4000",{"type":51,"coordinates":168},[169,170],-65.21051,-26.81601,{"lat":170,"lon":169},{"facility":173,"status":174,"city":175,"state":176,"zip":177,"country":178,"countryCode":179,"cosmosGeoPoint":180,"geoPoint":184,"contacts":30},"Manipal Hospital","ACTIVE_NOT_RECRUITING","Bangalore","Karnataka","560 017","India","IN",{"type":51,"coordinates":181},[182,183],77.59369,12.97194,{"lat":183,"lon":182},{"facility":186,"status":174,"city":187,"state":176,"zip":188,"country":178,"countryCode":179,"cosmosGeoPoint":189,"geoPoint":193,"contacts":30},"KLES Dr Prabhakar Kore Hospital and Medical Research Centre","Belagavi","590010",{"type":51,"coordinates":190},[191,192],74.50447,15.85212,{"lat":192,"lon":191},{"facility":195,"status":174,"city":196,"state":197,"zip":198,"country":178,"countryCode":179,"cosmosGeoPoint":199,"geoPoint":203,"contacts":30},"Fortis Flt Lt Rajan Dhall Hospital","New Delhi","National Capital Territory of Delhi","110 070",{"type":51,"coordinates":200},[201,202],77.2148,28.62137,{"lat":202,"lon":201},{"facility":205,"status":174,"city":196,"state":197,"zip":206,"country":178,"countryCode":179,"cosmosGeoPoint":207,"geoPoint":209,"contacts":30},"All India Institute of Medical Sciences","110029",{"type":51,"coordinates":208},[201,202],{"lat":202,"lon":201},{"facility":211,"status":174,"city":196,"state":197,"zip":212,"country":178,"countryCode":179,"cosmosGeoPoint":213,"geoPoint":215,"contacts":30},"Sir Ganga Ram 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Petersburg","198205",{"type":51,"coordinates":273},[274,275],30.31413,59.93863,{"lat":275,"lon":274},{"facility":278,"status":58,"city":279,"state":30,"zip":280,"country":261,"countryCode":262,"cosmosGeoPoint":281,"geoPoint":285,"contacts":30},"State Budgetary Healthcare Institution Samara Regional Clinical Hospital na V D Seredavin","Samara","443095",{"type":51,"coordinates":282},[283,284],50.13553,53.20767,{"lat":284,"lon":283},{"facility":287,"status":44,"city":288,"state":30,"zip":289,"country":288,"countryCode":290,"cosmosGeoPoint":291,"geoPoint":295,"contacts":30},"National University Hospital","Singapore","119074","SG",{"type":51,"coordinates":292},[293,294],103.85007,1.28967,{"lat":294,"lon":293},{"facility":297,"status":58,"city":298,"state":30,"zip":299,"country":300,"countryCode":30,"cosmosGeoPoint":301,"geoPoint":305,"contacts":30},"Asan Medical Center","Seoul","05505","South 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City","81362","Taiwan","TW",{"type":51,"coordinates":328},[329,330],120.31333,22.61626,{"lat":330,"lon":329},{"facility":333,"status":58,"city":334,"state":30,"zip":335,"country":325,"countryCode":326,"cosmosGeoPoint":336,"geoPoint":340,"contacts":30},"National Cheng Kung University Hospital","Tainan","70403",{"type":51,"coordinates":337},[338,339],120.21333,22.99083,{"lat":339,"lon":338},{"facility":342,"status":44,"city":343,"state":30,"zip":344,"country":325,"countryCode":326,"cosmosGeoPoint":345,"geoPoint":349,"contacts":30},"National Taiwan University Hospital","Taipei","10041",{"type":51,"coordinates":346},[347,348],121.52639,25.05306,{"lat":348,"lon":347},{"facility":351,"status":44,"city":352,"state":30,"zip":353,"country":325,"countryCode":326,"cosmosGeoPoint":354,"geoPoint":358,"contacts":30},"Linkou Chang Gung Memorial Hospital","Taoyuan","33305",{"type":51,"coordinates":355},[356,357],121.29696,24.99368,{"lat":357,"lon":356},{"facility":360,"status":44,"city":361,"state":30,"zip":362,"country":363,"countryCode":30,"cosmosGeoPoint":364,"geoPoint":368,"contacts":30},"Hacettepe Universitesi Tip Fakultesi Hastanesi","Ankara","06230","Turkey (Türkiye)",{"type":51,"coordinates":365},[366,367],32.85427,39.91987,{"lat":367,"lon":366},{"facility":370,"status":44,"city":361,"state":30,"zip":371,"country":363,"countryCode":30,"cosmosGeoPoint":372,"geoPoint":374,"contacts":30},"Baskent Universitesi Ankara Hastanesi","06490",{"type":51,"coordinates":373},[366,367],{"lat":367,"lon":366},{"facility":376,"status":44,"city":361,"state":30,"zip":377,"country":363,"countryCode":30,"cosmosGeoPoint":378,"geoPoint":380,"contacts":30},"Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi","06500",{"type":51,"coordinates":379},[366,367],{"lat":367,"lon":366},{"facility":382,"status":44,"city":361,"state":30,"zip":383,"country":363,"countryCode":30,"cosmosGeoPoint":384,"geoPoint":386,"contacts":30},"Ankara Bilkent Sehir Hastanesi","06800",{"type":51,"coordinates":385},[366,367],{"lat":367,"lon":366},{"facility":388,"status":44,"city":389,"state":30,"zip":390,"country":363,"countryCode":30,"cosmosGeoPoint":391,"geoPoint":395,"contacts":30},"Firat Universitesi Tip Fakultesi Hastanesi","Elâzığ","23200",{"type":51,"coordinates":392},[393,394],39.22321,38.67431,{"lat":394,"lon":393},{"facility":397,"status":44,"city":398,"state":30,"zip":399,"country":363,"countryCode":30,"cosmosGeoPoint":400,"geoPoint":404,"contacts":30},"Istanbul Universitesi Cerrahpasa Tip Fakultesi","Istanbul","34098",{"type":51,"coordinates":401},[402,403],28.94966,41.01384,{"lat":403,"lon":402},{"facility":406,"status":44,"city":398,"state":30,"zip":407,"country":363,"countryCode":30,"cosmosGeoPoint":408,"geoPoint":410,"contacts":30},"Marmara Universitesi Tip Fakultesi Hastanesi","34890",{"type":51,"coordinates":409},[402,403],{"lat":403,"lon":402},{"facility":412,"status":44,"city":413,"state":30,"zip":414,"country":363,"countryCode":30,"cosmosGeoPoint":415,"geoPoint":419,"contacts":30},"Ege Universitesi Tip Fakultesi Hastanesi","Izmir","35040",{"type":51,"coordinates":416},[417,418],27.13838,38.41273,{"lat":418,"lon":417},{"facility":421,"status":44,"city":422,"state":30,"zip":423,"country":363,"countryCode":30,"cosmosGeoPoint":424,"geoPoint":428,"contacts":30},"Erciyes Universitesi Tip Fakultesi Hastanesi","Kayseri","38039",{"type":51,"coordinates":425},[426,427],35.48528,38.73222,{"lat":427,"lon":426},{"facility":430,"status":58,"city":431,"state":30,"zip":432,"country":433,"countryCode":434,"cosmosGeoPoint":435,"geoPoint":439,"contacts":30},"National Childrens Specializated Hospital Okhmadit","Kyiv","01135","Ukraine","UA",{"type":51,"coordinates":436},[437,438],30.5238,50.45466,{"lat":438,"lon":437},{"type":441,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100334387","phase-3-a-trial-of-etelcalcetide-in-pediatric-participants-with-secondary-hyperparathyroidism-and-chronic-kidney-disease-on-hemodialysis-100334387",false,"NCT03633708","A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis","Phase 3, Randomized, Open-label, Controlled, Multiple Dose, Efficacy, Safety, Pharmacokinetic, and Pharmacodynamic Study of Etelcalcetide in Pediatric Subjects 28 Days to \u003C 18 Years of Age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis","Inclusion criteria\n\n* Age of 28 days \\\u003C 18 years.\n* Dry weight ≥ 7 kg during screening.\n* Diagnosed with CKD and SHPT undergoing hemodialysis at the time of screening.\n* Diagnosis of SHPT with the mean of the 2 consecutive central laboratory iPTH values ≥ 300 pg\u002FmL (32 pmol\u002FL) during screening, on separate days and within 2 weeks of enrolment.\n* Serum corrected calcium (cCa) value ≥ 9.0 mg\u002FdL (2.25 mmol\u002FL) for participants ≥ 2 years of age and older and serum cCa value ≥ 9.6 mg\u002FdL (2.4 mmol\u002FL) for participants 28 days to \\\u003C 2 years of age obtained from the central laboratory during screening.\n* Dialysate Ca level ≥ 2.5 mEq\u002FL during screening for at least 4 weeks prior to screening and throughout the duration of the trial.\n* No more than a maximum prescribed dose change of 50% for active vitamin D sterols\u002Fphosphate binders\u002FCa supplements within the 2 weeks prior to screening assessments and remain stable.\n* SHPT not due to vitamin D deficiency, per investigator assessment.\n\nExclusion Criteria Disease Related\n\n* History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrhythmia's or other conditions associated with prolonged QT interval.\n* Anticipated or scheduled parathyroidectomy during the trial period.\n* Anticipated or scheduled kidney transplant during the trial period.\n* Participant has received a parathyroidectomy within 6 months prior to randomization.\n\nOther Medical Conditions\n\n• History of other malignancy, except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years.\n\nPrior\u002FConcomitant Therapy\n\n* Use of concomitant medications that may prolong the corrected QT interval (eg, ondansetron, albuterol, sotalol, amiodarone, erythromycin, or clarithromycin). Refer to CredibleMeds.org for guidance. Certain medications may be allowed based on review by the medical monitor and require additional electrocardiogram (ECG) monitoring and potential electrolyte monitoring.\n* Receipt of cinacalcet therapy within 30 days prior to screening assessments and through randomization.\n* Receipt of etelcalcetide within 6 months prior to screening assessments and through randomization.\n* All herbal medicines (eg, St. John's wort), vitamins, and supplements consumed by the participant within the 30 days prior to randomization, and continuing use if applicable, will be reviewed by the Principal Investigator and the Amgen Medical Monitor. Written documentation of the review and Amgen acknowledgment is required for participant participation.\n* Use of any over-the-counter or prescription medications within the 14 days or 5 half-lives (whichever is longer) prior to randomization that are not established therapies for participants with renal disease or other conditions secondary to renal disease will be reviewed by the Principal Investigator and the Amgen Medical Monitor. Written documentation of the review and Amgen acknowledgment is required for participant participation. Paracetamol for analgesia will be allowed.\n\nPrior\u002FConcurrent Clinical Trial Experience • Currently receiving treatment in another investigational device or drug trial, or less than 30 days or 5 half-lives (whichever is longer) since ending treatment on another investigational device or drug trial(s). Other investigational procedures while participating in this trial are excluded.\n\nDiagnostic Assessments During Screening\n\n* Participant has significant abnormalities on the most recent central laboratory test during the screening period prior to enrollment per the Investigator including but not limited to the following: a. Serum transaminase (alanine aminotransferase \\[ALT\\] or serum glutamic pyruvic transaminase \\[SGPT\\], aspartate aminotransferase \\[AST\\] or serum glutamic oxaloacetic transaminase \\[SGOT\\]) \\> 2.0 times the upper limit of normal (ULN).\n* Corrected QT interval (QTc) \\> 500 ms, using Bazett's formula.\n* QTc ≥ 450 to ≤ 500 ms, using Bazett's formula, unless written permission to enroll is provided by the investigator after consultation with a pediatric cardiologist.\n* Participant has a clinically significant ECG abnormality during screening that, in the opinion of the investigator, could pose a risk to participant safety or interfere with the trial evaluation.\n\nWithin the 60 days prior to enrollment\n\n• New onset or worsening of a pre-existing seizure disorder.\n\nOther Exclusions\n\n* Participants aged 28 days to 6 months of age who were born prematurely at \\\u003C 36 weeks gestational age.\n* Female participant is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 3 months after the last dose of etelcalcetide. (Females of childbearing potential should only be included in the trial after a confirmed menstrual period and a negative highly sensitive serum pregnancy test within 7 days prior to the first dose of investigational product).\n* Female participants of childbearing potential unwilling to use 1 highly-effective or acceptable method of contraception during treatment and for an additional 3 months after the last dose of investigational product.\n* Participant has known sensitivity to etelcalcetide or excipients to be administered during dosing.\n* Participant likely to not be available to complete all protocol-required trial visits or procedures, and\u002For to comply with all required trial procedures (eg, to the best of the participant and investigator's knowledge).\n* History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the trial evaluation, procedures, or completion.\n* Participant has previously entered this trial.","ALL","0 Years","18 Years",{"count":453,"type":454},56,"ESTIMATED","INTERVENTIONAL",[457],"PHASE3","This is a phase 3 trial of etelcalcetide in pediatric participants with secondary hyperparathyroidism (SHPT) and chronic kidney disease (CKD) on hemodialysis.",[460,461],"Secondary Hyperparathyroidism","Chronic Kidney Disease",[463,464,465,460,466],"sHPT","CKD","pediatric","Chronic Kidney disease","2026-02-25",{"date":469,"type":470},"2026-02-27","ACTUAL",{"date":472,"type":470},"2019-04-29",{"date":474,"type":454},"2029-01-31",{"name":5,"class":6},43]