Vascular Calcification Clinical Trial
Official title:
The Effect of Etelcalcetide on Bone-tissue Properties and Calcification Propensity in End Stage Kidney Disease
The proposed study will investigate the effects of etelcalcetide on the bone and blood-vessel health in patients with CKD-MBD. The investigators will test if etelcalcetide makes bone and blood-vessels healthier. The study hypotheses are that are that etelcalcetide keeps bones strong and lowers the risk of calcium deposits in blood vessels. In Aim 1, the investigators will test if 9-months of treatment with etelcalcetide improves bone strength in twenty ESKD patients with hyperparathyroidism (HPT) by bone biopsy. In Aim 2, the investigators will test if 9-months of treatment with etelcalcetide decreases serum propensity to calcify blood vessels. The potential significance of this study is to provide first-time data on the ability of etelcalcetide to protect bone and blood-vessel health in patients with ESKD.
Chronic kidney disease - mineral and bone disease (CKD-MBD) is a disorder of bone and mineral metabolism in patients with CKD. When kidney function is poor, levels of vitamin D, phosphate and parathyroid hormone become abnormal and patients are at risk for bone disease and fractures (renal osteodystrophy) and the deposition of calcium in blood vessels and muscles. CKD-MBD increases the risk of fractures, heart attacks, strokes, and death. Treatment of CKD-MBD is focused on lowering levels of parathyroid hormone (PTH) by giving vitamin D and lowering levels of phosphorous by giving phosphate binders. In patients with end stage kidney disease (ESKD), target levels of PTH recommended by the Kidney Disease Improving Global Outcomes (KDIGO) guidelines are in the range of 2-9 times the upper limit of normal (ULN) for the PTH assay. In many cases, in patients with long-standing ESKD, the parathyroid gland may no longer respond to treatment with vitamin D and phosphate lowering. In these cases, treatment with a calcimimetic, a medicine that increases the sensitivity of the parathyroid gland to serum levels of calcium, can restore PTH levels to goal. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04983875 -
Mammography and Breast Arterial Calcification: An Information-Sharing Trial
|
N/A | |
Completed |
NCT03292029 -
Pilot Medical Evaluation of the T50 Test
|
N/A | |
Completed |
NCT02561299 -
Orbital Vessel PreparaTIon to MaximIZe Dcb Efficacy in Calcified Below the Knee (BTK) Lesions - A Pilot Study
|
N/A | |
Completed |
NCT00379899 -
ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis
|
Phase 4 | |
Active, not recruiting |
NCT02598635 -
Effects of Cholecalciferol on Osteoprotegerin Levels in Patients on Peritoneal Dialysis
|
Phase 4 | |
Completed |
NCT00183001 -
Effect of Vitamin K on Age-Related Bone Loss and Vascular Calcification
|
Phase 3 | |
Completed |
NCT04114695 -
Aortic Calcification and Central Blood Pressure in Patients With Chronic Kidney Disease
|
||
Not yet recruiting |
NCT03169400 -
Theranova Dialyzer and Chronic Kidney Disease - Mineral Bone Disorder (CKD-MBD)
|
N/A | |
Completed |
NCT03314493 -
Prevention of the Progression of Coronary Calcification With Use of Spironolactone in Peritoneal Dialysis Patients
|
Phase 3 | |
Completed |
NCT03839732 -
Observer Variability in Scoring Abdominal Aortic Calcifications and Vertebral Morphometry
|
||
Completed |
NCT02610933 -
Effect on Vascular Calcification of Replacing Warfarin by Rivaroxaban With or Without VitK2 in Hemodialysis Patients
|
Phase 4 | |
Completed |
NCT02542319 -
Effect of Oral Magnesium on Vascular Calcification in Chronic Kidney Disease
|
Phase 2 | |
Completed |
NCT00481364 -
Atorvastatin Treatment to Attenuate the Progression of Cardiovascular Disease in Hemodialysis Patients
|
Phase 3 | |
Completed |
NCT00694824 -
Vascular Calcification's Risk Factors in Haemodialysis Patients
|
||
Recruiting |
NCT01364688 -
Oral Alfacalcidol and Coronary Artery Calcification in Predialysis Chronic Kidney Disease
|
Phase 2 | |
Completed |
NCT01675206 -
Dose Defining Study for the Administration of Vitamin K2 Supplements in Hemodialysis Patients
|
Phase 3 | |
Completed |
NCT03937349 -
Impact of Parathyroidectomy on Cardiovascular Calcification in Dialysis-dependent Patients
|
||
Completed |
NCT02719665 -
THE OMEGA-SPM-DOSE and OMEGA-SPM-PAD: Specialized Pro-Resolving Mediators in Patients With Peripheral Artery Disease
|
N/A | |
Recruiting |
NCT04753593 -
Use of Discarded Surgery Human Tissue Specimens for Basic Science Research
|
||
Recruiting |
NCT06035783 -
Calcium Reduction by Orbital Atherectomy in Western Europe
|