protocolSection identificationModule nctId: NCT06352957, orgStudyIdInfo id: 23022022CERC, briefTitle: Use of ETElcalcetidefor pReserving vitamiN K-dependent proteIn activiTY ITAlian Study, acronym: ETERNITY-ITA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Istituto di Fisiologia Clinica CNR, class: OTHER, descriptionModule briefSummary: The goal of this Prospective Observational Study of comparative effectiveness is to provide real world evidence of the effect of Etelcalcetide in increasing actives form VKDPs levels such as BGP and MGP at 3, 9 and 18 months from baseline, with resulting correct bone mineralization and inhibition vascular calcification in hemodialysis patients.The study will enroll 160 hemodialysis patients: 80 patients treated with Etelcalcetide and 80 age and sex matched patients treated with Calcitriol or vitamin D analogs. The treating nephrologist will base the target dose of Etelcalcetide on individual-level in order to achieve the KDIGO PTH target. In the Etelcalcetide-treated group, the addition of calcitriol will be allowed when required by clinical practice (for correction of hypocalcemia). The main endpoint is the comparison of the levels of active forms of VKDP (MGP and BGP) between patients treated with Etelcalcetide and those treated with vitamin D or vitamin D analogues. The measurements of the biomarkers are scheduled at baseline and after 3, 9, and 18 months., conditionsModule conditions: Hemodialysis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Levels of VKDP, secondaryOutcomes measure: Calcium, secondaryOutcomes measure: Phosphate, secondaryOutcomes measure: Magnesium, secondaryOutcomes measure: ALP, secondaryOutcomes measure: PTH, secondaryOutcomes measure: 25(OH)D, secondaryOutcomes measure: P1NP, secondaryOutcomes measure: CTX, secondaryOutcomes measure: TRAP 5b, secondaryOutcomes measure: BSAP, secondaryOutcomes measure: cFGF23, secondaryOutcomes measure: Klotho, secondaryOutcomes measure: Sclerostin, secondaryOutcomes measure: DKK1, secondaryOutcomes measure: Fetuin A, secondaryOutcomes measure: Zinc, secondaryOutcomes measure: Irisin, secondaryOutcomes measure: Serum Calcification Propensity T50 test, secondaryOutcomes measure: Hemoglobin (Hb), secondaryOutcomes measure: Hematocrit (Ht), secondaryOutcomes measure: Plates (PLTS), secondaryOutcomes measure: Reticulocytes, secondaryOutcomes measure: Iron, secondaryOutcomes measure: Ferritin, secondaryOutcomes measure: Transferrin, secondaryOutcomes measure: Transferrin Saturation, secondaryOutcomes measure: Albumin, secondaryOutcomes measure: KT/V, secondaryOutcomes measure: Aluminium, secondaryOutcomes measure: C-reactive Protein (CRP), secondaryOutcomes measure: Cholesterol, secondaryOutcomes measure: Triglycerides, secondaryOutcomes measure: Cholesterol HDL, secondaryOutcomes measure: Cholesterol LDL, secondaryOutcomes measure: Vascular Calcification, secondaryOutcomes measure: Vertebral Fractures, secondaryOutcomes measure: BMD: Bone Mineral Density, secondaryOutcomes measure: Association between Verterbal Fractures and Vascular Calcificatiom, secondaryOutcomes measure: Novel quantitative computer-assisted scoring method for vascular calcifications., secondaryOutcomes measure: Effect of Etelcalcetide on cardiovascular events and all-cause mortality., secondaryOutcomes measure: Etelcalcetide Safety: Number of participants with treatment-related adverse events., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False