Preprint Article Version 1 This version is not peer-reviewed

Rationale and Protocol of ETERNITY-ITA Study: Use of Etelcalcetide for Preserving Vitamin K-Dependent Protein Activity Italian Study

Maria Fusaro
* ,
Andrea Aghi
,
Carmela Marino
,
Francesca Mallamaci
,
Mario Plebani
,
Martina Zaninotto
,
Maria Grano
,
Silvia Concetta Colucci
,
Maurizio Gallieni
,
Thomas L. Nickolas
,
Sandro Giannini
,
Stefania Sella
,
Paolo Simioni
,
Alberto Bazzocchi
,
Giuseppe Guglielmi
,
Fulvia Taddei
,
Enrico Schileo
,
Maria Carmela Versace
,
Giovanni Luigi Tripepi
Version 1 : Received: 12 August 2024 / Approved: 13 August 2024 / Online: 14 August 2024 (07:14:25 CEST)

How to cite: Fusaro, M.; Aghi, A.; Marino, C.; Mallamaci, F.; Plebani, M.; Zaninotto, M.; Grano, M.; Colucci, S. C.; Gallieni, M.; Nickolas, T. L.; Giannini, S.; Sella, S.; Simioni, P.; Bazzocchi, A.; Guglielmi, G.; Taddei, F.; Schileo, E.; Versace, M. C.; Tripepi, G. L. Rationale and Protocol of ETERNITY-ITA Study: Use of Etelcalcetide for Preserving Vitamin K-Dependent Protein Activity Italian Study. Preprints 2024, 2024080995. https://doi.org/10.20944/preprints202408.0995.v1 Fusaro, M.; Aghi, A.; Marino, C.; Mallamaci, F.; Plebani, M.; Zaninotto, M.; Grano, M.; Colucci, S. C.; Gallieni, M.; Nickolas, T. L.; Giannini, S.; Sella, S.; Simioni, P.; Bazzocchi, A.; Guglielmi, G.; Taddei, F.; Schileo, E.; Versace, M. C.; Tripepi, G. L. Rationale and Protocol of ETERNITY-ITA Study: Use of Etelcalcetide for Preserving Vitamin K-Dependent Protein Activity Italian Study. Preprints 2024, 2024080995. https://doi.org/10.20944/preprints202408.0995.v1

Abstract

Background and objectives: Chronic Kidney Disease and Mineral Bone Disorders (CKD-MBD) are frequently associated with an increased risk of both Vascular Calcifications (VCs) and bone fractures (BFs). The complex pathogenesis of VCs and BFs involves various factors such as calcium overload, phosphate imbalance, and secondary hyperparathyroidism. Key players, such as the vitamin K-dependent proteins (VKDPs) matrix Gla protein (MGP) and osteocalcin (BGP), have pivotal roles both for VCs and BFs. The Vitamin K Italian (VIKI) dialysis study, highlighted that hemodialysis patients treated with calcimimetics had higher levels of total BGP and MGP as compared to those untreated, suggesting a potential protective effect of these drugs on BFs and VCs, beyond the beneficial effect to reduce PTH levels. Methods: ETERNITY-ITA is a multi-center, comparative effectiveness, observational, longitudinal study that will enroll 160 hemodialysis patients (80 patients treated with Etelcalcetide and 80 age and sex-matched patients treated with Calcitriol or vitamin D analogs). Nephrologists will tailor the target dose of Etelcalcetide on individual level 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). Conclusion: The study will evaluate the real-world effect of Etelcalcetide on VKDP levels, such as BGP and MGP, at 3, 9, and 18 months from baseline. The resulting preservation of vascular and bone health will be assessed for the first time by examining aortic and iliac artery calcifications and vertebral fractures, respectively. Keywords: bone fractures; etecalcetide; hemodialysis; vascular calcification; vitamin K

Keywords

Bone fractures; Etecalcetide; Hemodialysis; Vascular calcification; Vitamin K.

Subject

Medicine and Pharmacology, Medicine and Pharmacology

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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