Your session is about to expire
← 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 6, month 12, month 18, month 24
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am on hemodialysis and my mammogram shows breast arterial calcification.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
1,636 Previous Clinical Trials
2,560,538 Total Patients Enrolled
W. Charles O'Neill, MDPrincipal InvestigatorEmory University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking warfarin.I am unable to understand and give consent for treatment.You are expected to live less than 2 years.I am likely to need surgery for severe parathyroid gland issues within 2 years.I have trouble managing my blood calcium levels.I am on hemodialysis and my mammogram shows breast arterial calcification.
Research Study Groups:
This trial has the following groups:- Group 1: Citrate Dialysate then Standard Dialysate
- Group 2: Standard Dialysate
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the aggregate amount of individuals participating in this clinical trial?
"Affirmative. According to clinicaltrials.gov, this medical examination is currently enrolling patients, having first been posted on June 2nd 2021 and subsequently amended on July 1st 2022. A total of 62 individuals need to be recruited from four different centres for the trial's completion."
Answered by AI
Is there room for additional participants in this clinical investigation?
"Affirmative. Clinicaltrials.gov declares that this experiment, first posted on June 2nd 2021 and most recently updated on July 1st 2022, is actively recruiting participants. Around 62 individuals are sought from 4 distinct clinical sites."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger