Citrate Dialysis for Vascular Calcification
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment Phase 1
Participants receive hemodialysis using either a citrate or non-citrate dialysate for 12 months
Treatment Phase 2
Participants switch to the alternate dialysate solution for another 12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Citrate Dialysate
- Standard Dialysate
Find a Clinic Near You
Who Is Running the Clinical Trial?
Emory University
Lead Sponsor
Fresenius Medical Care Renal Therapies Group (FMCRTG)
Collaborator