Citrate Dialysis for Vascular Calcification

Recruiting at 3 trial locations

Overseen By W. Charles O'Neill, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Emory University

Must not be taking: Warfarin

Disqualifiers: Severe hyperparathyroidism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

53 Participants Needed

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

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

Group I: Citrate Dialysate then Standard Dialysate Experimental Treatment 2 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 Dialysate Active Control 2 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.

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+