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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

No Placebo-Only Group

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

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, month 6, month 12, month 18, month 24

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 4Eligibility criteria met