53 Participants Needed

Citrate Dialysis for Vascular Calcification

Recruiting at 3 trial locations
WC
Overseen ByW. Charles O'Neill, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Emory University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

WC

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Participants receive hemodialysis using either a citrate or non-citrate dialysate for 12 months

12 months
Mammograms and blood samples every 6 months

Treatment Phase 2

Participants switch to the alternate dialysate solution for another 12 months

12 months
Mammograms and blood samples every 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Citrate Dialysate
  • Standard Dialysate
Trial Overview The 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 Dialysate then Citrate 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

Fresenius Medical Care Renal Therapies Group (FMCRTG)

Collaborator

Trials
1
Recruited
50+
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