[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"secondary-hyperparathyroidism\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:secondary-hyperparathyroidism":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,48,78,105,133,155],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100506940","precision-medicine-approaches-to-renal-osteodystrophy-100506940",false,"NCT05880914","Precision Medicine Approaches to Renal Osteodystrophy","PMaROD","Inclusion Criteria:\n\n1. Study participant has provided informed consent\n2. Age ≥ 18 years\n3. CKD Stages 3-5D regardless of kidney transplantation status\n4. CKD5D patients receiving maintenance hemodialysis for at least 3 months\n5. Clinically indicated treatment for renal hyperparathyroidism, renal osteodystrophy and\u002For Osteoporosis\n6. PTH, BSAP and CTX meets defined thresholds for low or high turnover ROD type or a Bone biopsy evidence of low or high turnover based\n\nExclusion Criteria:\n\n1. Currently receiving treatment in an investigational device or drug study, or less than 30 days since ending treatment on an investigational device or drug study(s)\n2. Currently receiving investigational procedures\u002Fdrugs from another study while participating in this study\n3. Use of etelcalcetide, bisphosphonate, denosumab, teriparatide, abaloparatide or romosozumab during the 6 months prior to study enrollment; however, participant can be included if being treated with bone active agent but will have class change to an agent that will result in a change in bone turnover from low to high or high to low\n4. New use of cinacalcet over the prior 6 months\n5. Use of Zoledronic Acid (Reclast) less than 24 months from study enrollment for patients with eGFR \\\u003C30mL\u002Fminute\n6. Anticipated or scheduled kidney transplant during the study period or less than 1 year from receiving a kidney transplant\n7. For patients with a solid organ transplant, less than 1 year from receiving the transplant\n8. Patient has an unstable medical condition based on medical history, physical examination, and routine laboratory tests, or is otherwise unstable in the judgment of the Investigator\n9. Metabolic bone diseases not related to the kidney (e.g., Paget's, Osteogenesis Imperfecta)\n10. Endocrinopathy (e.g., untreated hyperthyroidism)\n11. Malignancy within the last 5 years (except non-melanoma skin cancers or cervical carcinoma in situ)\n12. Patient is pregnant or nursing\n13. Weight \\>300 pounds (scanner limitation)\n14. Allergy to tetracycline or demeclocycline\n15. Patients on non-aspirin anticoagulants that cannot be reasonably held for biopsy\n16. Patient unable to complete all protocol-required study visits or procedures, and\u002For to comply with all required study procedures to the best of the patient and Investigator's knowledge","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","OBSERVATIONAL","Treatment of renal osteodystrophy is impeded by the lack of practical and accurate tools to determine underlying bone turnover. Gold standard bone biopsy is not practical in the clinic for the vast majority of kidney disease patients and parathyroid hormone and bone alkaline phosphatase have insufficient accuracy for turnover type to safely and confidently guide treatment of renal osteodystrophy. In the present investigation, the investigators will study a microRNA approach as a novel non-invasive biomarker of turnover for renal osteodystrophy.",[24,25,26,27,28],"Renal Osteodystrophy","Chronic Kidney Diseases","CKD-MBD","Bone Turnover Rate Disorder","Secondary Hyperparathyroidism",[30,31,32,33,34],"Bone biopsy","microRNA","HR-pQCT","Bone biomarkers","Bone imaging","RECRUITING","2026-06-11",{"date":38,"type":39},"2026-06-12","ACTUAL",{"date":41,"type":39},"2022-12-21",{"date":43,"type":20},"2027-06-30",{"name":45,"class":46},"Thomas Nickolas","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100630928","phase-2-pharmacokinetics-pharmacodynamics-safety-and-tolerability-evaluation-of-ctap101-extended-release-capsules-in-pediatric-participants-100630928","NCT07494045","Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Evaluation of CTAP101 Extended-release Capsules in Pediatric Participants","An Open-Label, Randomized, Multiple-Dose, Multi-Center Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of CTAP101 Extended-release Capsules in Pediatric Participants \u003C18 Years of Age With Secondary Hyperparathyroidism, Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency","Inclusion Criteria:\n\nEach participant must meet the following criteria to be enrolled in Cohort 1 of this study:\n\n1. Be 8 to \\\u003C18 years of age with a body weight of ≥40 kg.\n2. Be diagnosed with stage 3 or 4 CKD at least six months prior to the screening visit (Visit 1) and have an eGFR of ≥15 to \\\u003C60 mL\u002Fmin\u002F1.73m2 at screening.\n3. Be without any disease state or physical condition that might impair evaluation of safety or which, in the investigator's opinion, would interfere with study participation.\n4. Exhibit during the initial or, if necessary, a screening visit after washout:\n\n   1. Plasma iPTH \\>85 pg\u002FmL;\n   2. Serum Ca \\\u003C9.8 mg\u002FdL;\n   3. Serum P ≤5.5 mg\u002FdL; and\n   4. Serum 25D \\\u003C30 ng\u002FmL.\n5. If taking calcitriol or other 1α-hydroxylated vitamin D therapy, be willing to forgo treatment with these agents for the duration of the study and complete a 2-week washout period prior to commencing treatment in the study.\n6. If receiving ≤2,000 IU\u002Fday or 50,000 IU\u002Fmonth (1,250 mcg) vitamin D supplementation (ergocalciferol or cholecalciferol) therapy, must agree to remain on a stable dose during the study.\n7. If taking \\>2,000 IU\u002Fday of vitamin D supplementation, must discontinue or decrease the dose to ≤2,000 IU\u002Fday, maintain that dose for the duration of the study and complete a 2-week washout period prior to commencing treatment in the study.\n8. If taking \\>1000 mg\u002Fday of elemental Ca through Ca-based phosphate binder or antacid therapy, must discontinue or decrease the dose to ≤ 1000 mg\u002Fday, maintain that dose for the duration of the study, and complete a 2-week washout period prior to commencing treatment in the study.\n9. If taking any bone metabolism therapy that could interfere with study endpoints, must discontinue use of such agent(s) for the duration of the study.\n10. Willing and able to comply with study procedures and instructions and commit to all study visits for the duration of the study.\n11. Willing and able to safely swallow the CTAP101 capsules whole.\n12. Female participants of childbearing potential must be neither pregnant nor lactating and must have a negative urine pregnancy test at the first screening visit.\n13. All female participants of childbearing potential and male participants with female partners of childbearing potential must agree to use effective contraception (eg, implants, injectables, combined oral contraceptives, intrauterine device, sexual abstinence, vasectomy or vasectomized partner) for the duration of the study.\n14. Each participant or their legal representative must be able to read, understand and sign the ICF.\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria will be excluded from the study:\n\n1. Kidney transplant within the 26 weeks preceding screening or kidney transplant rejection within the 26 weeks preceding screening.\n2. No history of parathyroidectomy or planned parathyroidectomy.\n3. History (prior three months) of serum Ca ≥9.8 mg\u002FdL.\n4. Use of calcimimetic or calcifediol therapy within three months prior to consent.\n5. Use of bisphosphonate or denosumab therapy within six months prior to consent.\n6. Known or suspected hypersensitivity to any of the constituents in CTAP101 Capsules.\n7. Known previous or concomitant serious illness or medical condition, such as malignancy, human immunodeficiency virus, significant gastrointestinal or hepatic disease or cardiovascular event or hepatitis, or abnormal ECG or physical condition that in the opinion of the investigator may worsen and\u002For interfere with participation in the study.\n8. History of neurological\u002Fpsychiatric disorder, including psychotic disorder, or any reason which, in the opinion of the investigator makes adherence to a treatment or FU schedule unlikely.\n9. Currently participating in, or has participated in, an interventional\u002Finvestigational study within 30 days prior to study screening that in the opinion of the investigator and\u002For sponsor would interfere with the safety, assessments, and results of this study.","1 Month","17 Years",{"count":19,"type":20},"INTERVENTIONAL",[60],"PHASE2","The goal of this clinical trial is to evaluate safety, tolerability, and how CTAP101 Capsules work to treat Pediatric Participants with Secondary Hyperparathyroidism, Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency. The main questions it aims to answer are:\n\n1. To assess the pharmacokinetics (PK) and Pharmacodynamics (PD) of CTAP101 Capsules\n2. To investigate the safety and tolerability of CTAP101 Capsules\n\nParticipants will take a daily dosage of CTAP101 Capsules at bedtime for 8 weeks.",[63,64,28,65],"CKD Stage 3","CKD Stage 4","VDI","NOT_YET_RECRUITING","2026-03-25",{"date":69,"type":39},"2026-03-30",{"date":71,"type":20},"2026-06",{"date":73,"type":20},"2028-08",{"name":75,"class":76},"OPKO Health, Inc.","INDUSTRY",5,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":85,"maxAge":56,"enrollmentInfo":86,"targetDuration":4,"studyType":58,"phases":88,"briefSummary":90,"conditions":91,"keywords":92,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":102,"locationsCount":104},"100360147","phase-3-a-phase-3-study-of-etelcalcetide-in-children-with-secondary-hyperparathyroidism-receiving-hemodialysis-100360147","NCT03969329","A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis","Phase 3, Single-arm, Open-label, Multidose, Titration, Pharmacokinetic, Pharmacodynamic, and Safety Study of Etelcalcetide in Children and Adolescents ≥ 2 to \u003C 18 Years of Age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis","Inclusion Criteria:\n\n* Participant's legally acceptable representative has provided informed consent when the participant is legally too young to provide informed consent and the participant has provided written assent based on local regulations and\u002For guidelines prior to any trial-specific activities\u002Fprocedures being initiated.\n* Male or female participants greater than or equal to 2 to less than 18 years of age at the time of enrollment.\n* Targeted dry weight greater than or equal to 7 kg at the time of screening Week -1.\n* Diagnosed with CKD and SHPT undergoing hemodialysis\u002Fhemodiafiltration TIW or four times a week (QIW) at the time of screening greater than or equal to 1 month.\n* Diagnosis of SHPT with the mean of the 2 consecutive central laboratory iPTH values greater than 300 pg\u002FmL during screening, on separate days and within 2 weeks of enrollment obtained from the central laboratory during screening.\n* Serum corrected Ca value greater than or equal to 9.0 mg\u002FdL obtained from the central laboratory during screening.\n* Dialysate Ca level greater than or equal to 2.5 mEq\u002FL for at least 1 month prior to screening and throughout the duration of the trial.\n* participant receiving active vitamin D sterols must have had no more than a maximum dose change of 50% within the 2 weeks prior to screening laboratory assessments, remain stable through enrollment, and be expected to maintain stable doses for the duration of the trial, except for adjustments allowed per protocol.\n* participant receiving phosphate binders must have had no more than a maximum dose change of 50% within the 2 weeks prior to screening laboratory assessments, remain stable through enrollment, and be expected to maintain stable dose for the duration of the trial, except for adjustments allowed per protocol.\n* Subject receiving Ca supplements must have had no more than a maximum dose change of 50% within the 2 weeks prior to screening laboratory assessments, remain stable through enrollment, and be expected to maintain stable dose for the duration of the trial, except for adjustments allowed per protocol.\n* SHPT not due to vitamin D deficiency, per investigator assessment.\n\nExclusion Criteria:\n\n* Disease Related:\n* History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrhythmia's, history of symptomatic ventricular dysrhythmias Torsades de Pointes 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 enrollment.\n* Other Medical Conditions:\n* Current malignancy or history of other malignancy, except non-melanoma skin cancers within the last 5 years.\n* Prior\u002FConcomitant Therapy:\n* Use of concomitant medications that may prolong the QTc (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 and through enrollment.\n* Any previous use of etelcalcetide prior to screening and through enrollment (Original protocol, Amendment 1, and Amendment 2 only).\n* Receipt of etelcalcetide therapy within 6 months prior to screening assessments and through enrollment (Amendment 3 and later only).\n* All herbal medicines (eg, St. John's wort), vitamins, and supplements consumed by the participant within the 30 days prior to enrollment, 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 enrollment 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* Prior\u002FConcurrent Clinical Trial Experience:\n* Currently receiving treatment in another investigational device or drug trial, or less than 30 days since ending treatment on another investigational device or drug trial(s). Other investigational procedures while participating in this trial are excluded.\n* Diagnostic Assessments During Screening:\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\\]) greater than 1.5 times the upper limit of normal (ULN).\n* Corrected QT interval greater than 500 ms, using Bazett's formula.\n* Corrected QT interval greater than or equal to 450 to less than or equal 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 (eg, unstable arrhythmia) during screening that, in the opinion of the investigator, could pose a risk to participant safety or interfere with the trial evaluation.\n* Within the 3 Months Prior to Screening:\n* New onset or worsening of a pre-existing seizure disorder.\n* Participants on anti-convulsant medication must be on a stable and therapeutic dose for 3 months prior to screening (if blood level monitoring is clinically available, then the participant must have a therapeutic blood level within 1 week of enrollment).\n\nOther Exclusions:\n\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 effective contraception during treatment and for an additional 3 months after the last dose of investigational product.\n* Female participants of childbearing potential with a positive pregnancy test assessed at screening by a serum pregnancy test.\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 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) or unacceptable physical findings, 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 or previously received treatment with etelcalcetide (Original protocol, Amendment 1 and Amendment 2 only).\n* Participant previously has entered this trial (Amendment 3 and later only).\n* Anemia, which in the opinion of the investigator makes it not advisable to undergo sequential blood draws.\n* History of unstable chronic heart failure within the last 1 year prior to screening.","2 Years",{"count":87,"type":20},24,[89],"PHASE3","Assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in pediatric participants between ≥ 2 to \\\u003C 18 years of age, with chronic kidney disease (CKD) on hemodialysis.",[28],[93,94,95],"Secondary hyperparathyroidism (sHPT)","Chronic kidney disease (CKD)","Paediatric","2026-03-19",{"date":98,"type":39},"2026-03-23",{"date":100,"type":39},"2019-12-20",{"date":43,"type":20},{"name":103,"class":76},"Amgen",23,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":112,"maxAge":17,"enrollmentInfo":113,"targetDuration":4,"studyType":58,"phases":115,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},"100334387","phase-3-a-trial-of-etelcalcetide-in-pediatric-participants-with-secondary-hyperparathyroidism-and-chronic-kidney-disease-on-hemodialysis-100334387","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.","0 Years",{"count":114,"type":20},56,[89],"This is a phase 3 trial of etelcalcetide in pediatric participants with secondary hyperparathyroidism (SHPT) and chronic kidney disease (CKD) on hemodialysis.",[28,118],"Chronic Kidney Disease",[120,121,122,28,123],"sHPT","CKD","pediatric","Chronic Kidney disease","2026-02-25",{"date":126,"type":39},"2026-02-27",{"date":128,"type":39},"2019-04-29",{"date":130,"type":20},"2029-01-31",{"name":103,"class":76},43,{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":140,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":143,"conditions":144,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":47},"100525767","a-observational-study-to-evaluate-the-efficacy-and-safety-of-pacitol-inj-100525767","NCT06126016","A Observational Study to Evaluate the Efficacy and Safety of Pacitol Inj.","A Multi-center, Prospective, Non-interventional, Observational Study to Evaluate the Efficacy and Safety of Pacitol Inj.(Paricalcitol) for Secondary Hyperparathyroidism With Stage 5D Chronic Kidney Disease (CKD 5D) Receiving Hemodialysis","Inclusion Criteria:\n\n* Among hemodialysis patients with secondary hyperparathyroidism due to chronic kidney disease (CKD 5D), those who are scheduled to administer Pacitol Inj. according to the product information.\n* Those who voluntarily signed a written personal information collection and usage agreement to participate in this clinical study after receiving an explanation about the objective and methods of the study.\n* Those able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion.\n\nExclusion Criteria:\n\n* Those with a history of hypersensitivity reactions to this drug or its components\n* Those with evidence of vitamin D toxicity\n* Those with hypercalcemia at enrollment\n* Pregnant or lactating women\n* Those with evidence of parathyroid adenoma who is scheduled to undergo parathyroidectomy.\n* Those who have been administered with investigational drugs of other clinical trials within 12 weeks from the baseline(Visit 1).\n* Those who are judged by the principle Investigator or sub-Investigator to be ineligible to participate in the study.","19 Years",{"count":142,"type":20},1000,"The purpose of this study is to evaluate the efficacy and safety of pacitol Inj.(paricalcitol) for secondary hyperparathyroidism with stage 5D chronic kidney disease (CKD 5D) receiving hemodialysis",[145,28],"Chronic Kidney Disease 5D","2024-12-10",{"date":148,"type":39},"2024-12-12",{"date":150,"type":39},"2023-10-19",{"date":152,"type":20},"2026-04",{"name":154,"class":76},"Boryung Pharmaceutical Co., Ltd",{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":58,"phases":165,"briefSummary":167,"conditions":168,"keywords":170,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":183,"locationsCount":47},"100557761","intraoperative-parathyroid-hormone-monitoring-to-guide-surgery-in-renal-hyperparathyroidism-100557761","NCT06542315","Intraoperative Parathyroid Hormone Monitoring to Guide Surgery in Renal hyperparathyroIdism","Intraoperative Parathyroid Hormone Monitoring to Guide Surgery in Renal hyperparathyroIdism: A Pilot Trial","PEREGRINE","Inclusion Criteria:\n\n* 18 years of age or older\n* Candidate for subtotal parathyroidectomy or total thyroidectomy with or without autotransplantation\n* Tertiary hyperparathyroidism and\u002For recurrent hyperparathyroidism OR secondary hyperparathyroidism diagnosed with any stage of chronic kidney disease\n\nExclusion Criteria:\n\n* Undergoing parathyroidectomy for primary hyperparathyroidism\n* Pregnant or breastfeeding women\n* Undergoing revision parathyroidectomy\n* Undergoing minimally invasive or video-assisted parathyroidectomy\n* Unable to provide written consent to be participant in study\n* Unable to complete study follow-up visits",{"count":164,"type":20},60,[166],"NA","The goal of this pilot clinical is to determine the feasibility of a fully powered clinical trial to determine the effectiveness of intraoperative parathyroid hormone (IOPTH) criteria in guiding surgery for secondary and tertiary hyperparathyroidism. The main question it aims to answer is:\n\nIs a fully powered trial investigating the role for IOPTH criteria in secondary and tertiary hyperparathyroidism feasible?\n\nThe comparison group is surgery not guided by IOPTH.\n\nParticipants will be randomized to undergo parathyroid surgery with one of four IOPTH criteria or a control arm that does not use IOPTH. All recruited patients are asked to complete quality of life and cognitive questionnaires, in addition to bloodwork during the study period.",[28,169],"Tertiary Hyperparathyroidism",[171,172,173,174,175,176],"hyperparathyroidism","secondary hyperparathyroidism","tertiary hyperparathyroidism","chronic kidney disease","renal transplantation","pilot trial","2024-08-04",{"date":179,"type":39},"2024-08-07",{"date":181,"type":20},"2024-10",{"date":71,"type":20},{"name":184,"class":46},"McMaster University"]