Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06352957
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-03-21
Brief Title:
Use of ETElcalcetidefor pReserving vitamiN K-dependent proteIn activiTY ITAlian Study
Sponsor:
Istituto di Fisiologia Clinica CNR
Organization:
Istituto di Fisiologia Clinica CNR
Study Overview
Official Title:
Use of ETElcalcetidefor pReserving vitamiN K-dependent proteIn activiTY ITAlian Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ETERNITY-ITA
Brief Summary:
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
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
Detailed Description:
Vascular calcifications VCs are frequent complications of chronic kidney disease CKD and mineral disorders are associated with aortic calcifications and increased risk of bone fractures The complex pathogenesis of VCs involves various factors such as calcium overload phosphate imbalance and secondary hyperparathyroidism Key inhibitors such as vitamin K-dependent proteins VKDPs like matrix Gla protein MGP play pivotal roles in VCs development Traditional treatments to reduce VC focus on lowering PTH calcium and phosphorus levels and etelcalcetide revealed as a promising therapy to this scope Accordingly the VItamin K Italian study VIKI reported that calcimimetics treated hemodialysis patients had higher levels of total BGP and MGP versus those untreated suggesting a protective effect of this drugs class These findings point out the multifactorial nature of VC in CKD and suggest new treatment strategies and targeted pathways for improving outcomes The ETERNITY-ITA study will investigate the real world effect of Etelcalcetide in increasing actives form VKDPs levels such as BGP and MGP thus contributing to bone and vascular health in hemodialysis patients ETERNITY-ITA is a multi-center comparative effectiveness observational longitudinal study 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None