Clinical Trials Logo

Clinical Trial Summary

The goal of this study is to determine whether hemodialysis with citrate slows the progression of vascular calcification. Participants will be dialyzed with one of two standard dialysis solutions, one with and one without citrate, for 12 months and then switched to the other solution for 12 months. Vascular calcification will be measured on mammograms that will be performed at 6-month intervals and additional blood samples will be obtained at 6-month intervals.


Clinical Trial Description

Vascular calcification is a significant problem in dialysis patients that leads to poor outcomes. Currently there is no therapy that directly addresses this problem. Some of the dialysis solutions (dialysates) currently in use contain citrate, a potent inhibitor of calcium precipitation. In particular, citrate can bind to nascent hydroxyapatite crystals and prevent their propagation. Blood citrate levels are greater after dialysis with citrate dialysates than with non-citrate dialysates, which could slow vascular calcification. However, this has never been investigated. Prior research has shown that arterial calcification can be easily detected and reliably measured on routine digital mammograms, with sufficient sensitivity to follow progression. Mammography is more sensitive in detecting arterial calcification than other imaging and associated with far less radiation and cost. This will allow the researchers to detect differences between citrate and non-citrate dialysates in a safe and convenient way. Participants will be dialyzed with one of two standard dialysis solutions, one with and one without citrate, for 12 months and then switched to the other solution for 12 months. Vascular calcification will be measured by mammography every 6 months. The endpoint will be the difference in the rate of progression of breast arterial calcification (BAC) between dialysis with citrate and non-citrate dialysates. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04956120
Study type Interventional
Source Emory University
Contact
Status Active, not recruiting
Phase N/A
Start date June 2, 2021
Completion date December 2024

See also
  Status Clinical Trial Phase
Completed NCT03960437 - The Effect of Etelcalcetide on CKD-MBD Phase 2
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 NCT02542319 - Effect of Oral Magnesium on Vascular Calcification in Chronic Kidney Disease Phase 2
Completed NCT02610933 - Effect on Vascular Calcification of Replacing Warfarin by Rivaroxaban With or Without VitK2 in Hemodialysis Patients Phase 4
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