Citrate Dialysis for Vascular Calcification

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byW. Charles O'Neill, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Emory University

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

W. Charles O'Neill, MD

Principal Investigator

Emory University

Eligibility Criteria

This trial is for hemodialysis patients who have vascular calcification visible on mammograms. It's not suitable for those with a life expectancy under 2 years, current warfarin users, individuals unable to consent, prisoners, or those with severe hyperparathyroidism or calcium control issues.

Inclusion Criteria

I am on hemodialysis and my mammogram shows breast arterial calcification.

Exclusion Criteria

I am currently taking warfarin.

I am unable to understand and give consent for treatment.

Prisoners

See 3 more

Treatment Details

Interventions

Citrate Dialysate (Other)
Standard Dialysate (Other)

Trial OverviewThe study tests if hemodialysis using citrate can slow down the hardening of blood vessels compared to standard dialysis solutions. Participants will use one solution for a year and then switch to the other for another year while their vascular health is monitored.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Citrate Dialysate then Standard DialysateExperimental Treatment2 Interventions

Participants receiving hemodialysis using a citrate acid concentrate dialysate for the first year of the study, then receiving hemodialysis using a non-citrate acid concentrate dialysate (standard dialysate) for the second year of the study.

Group II: Standard DialysateActive Control2 Interventions

Participants receiving hemodialysis using a non-citrate acid concentrate dialysate for the first year of the study, then receiving hemodialysis using a citrate acid concentrate dialysate for the second year of the study.