Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT06352957
Study type Observational
Source Istituto di Fisiologia Clinica CNR
Contact Maria Fusaro, MD
Phone 0965393253
Email dante.lucia11@gmail.com
Status Not yet recruiting
Phase
Start date May 1, 2024
Completion date December 31, 2027

See also
  Status Clinical Trial Phase
Recruiting NCT04892745 - Impact of Hemodialysis on Cutaneo-muscular Electrical Impedance
Not yet recruiting NCT04925674 - Study of HEC53856 in Patients With Subjects With End-Stage Renal Disease Receiving Dialysis. Phase 1
Active, not recruiting NCT03183245 - Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis Phase 3
Completed NCT03365635 - Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C Phase 4
Withdrawn NCT02904343 - Evaluation of Domestic Hemodialysis Machine: A Multi-center Clinical Study N/A
Withdrawn NCT01855334 - L-Arginine and Spironolactone Trial in Dialysis-Dependent ESRD Phase 4
Completed NCT01700465 - Estimating and Predicting Hemodynamic Changes During Hemodialysis N/A
Recruiting NCT01195519 - The Assessment of Quality of Life in Patients With Peritoneal Dialysis and Hemodialysis N/A
Completed NCT00737672 - GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis Phase 3
Completed NCT00527774 - Effect of HCV Infection on Insulin Resistance and Malnutrition-inflammation Complex Syndrome in Regular Hemodialysis Patients N/A
Completed NCT00942253 - Exercise Training in Dialysis Patients With Restless Legs Syndrome (RLS) Phase 2
Completed NCT00850252 - Use of a Lifeline Graft in the A-V Shunt Model Phase 1/Phase 2
Completed NCT00224081 - DRIVE Trial (Dialysis Patients' Response to Intravenous [IV] Iron With Elevated Ferritin) Phase 4
Completed NCT00776750 - Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients Phase 4
Recruiting NCT06351007 - Educational Program on Dietary Adherence and Nutritional Knowledge in Chronic Kidney Disease Patients (EPAK) N/A
Withdrawn NCT03664141 - Impact of Cannabis Oil on Nutrition in Hemodialysis Patients Study (ICON-HP Study) Phase 3
Completed NCT03909698 - Antibiotic Dosing in Patients on Intermittent Hemodialysis
Recruiting NCT03311321 - Vitamin K to Slow Progression of Cardiovascular Disease Risk in Hemodialysis Patients N/A
Recruiting NCT06098924 - HD Patients' Depression and Happiness
Recruiting NCT03419923 - Three Anticoagulation Strategies for Hemodialysis in Patients at Risk of Hemorrhage N/A