← Back to Search

Other

Citrate Dialysis for Vascular Calcification

N/A
Waitlist Available
Led By W. Charles O'Neill, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Hemodialysis patients with BAC on mammograms
Be older than 18 years old
Must not have
Current warfarin use
Inability to give consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 6, month 12, month 18, month 24
Awards & highlights

Summary

This trial will test whether dialysis with citrate can help slow the progression of vascular calcification.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include changes in blood mineral levels due to different dialysate compositions which could affect bone and heart health. Regular monitoring aims to manage these risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am on hemodialysis and my mammogram shows breast arterial calcification.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently taking warfarin.
Select...
I am unable to understand and give consent for treatment.
Select...
I am likely to need surgery for severe parathyroid gland issues within 2 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 6, month 12, month 18, month 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 6, month 12, month 18, month 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in rate of progression of breast arterial calcification (BAC)

Trial Design

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.

Find a Location

Who is running the clinical trial?

Fresenius Medical Care Renal Therapies Group (FMCRTG)UNKNOWN
Emory UniversityLead Sponsor
1,679 Previous Clinical Trials
2,583,631 Total Patients Enrolled
W. Charles O'Neill, MDPrincipal InvestigatorEmory University

Media Library

Citrate Dialysate (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04956120 — N/A
Vascular Calcification Research Study Groups: Citrate Dialysate then Standard Dialysate, Standard Dialysate
Vascular Calcification Clinical Trial 2023: Citrate Dialysate Highlights & Side Effects. Trial Name: NCT04956120 — N/A
Citrate Dialysate (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04956120 — N/A
~2 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top