- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04956120
Effect of Citrate Dialysis on Vascular Calcification
August 8, 2023 updated by: Charles O'Neill, Emory University
Effect of Citrate Dialysate on Vascular Calcification
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Vascular calcification is a significant problem in dialysis patients that leads to poor outcomes.
Currently there is no therapy that directly addresses this problem.
Some of the dialysis solutions (dialysates) currently in use contain citrate, a potent inhibitor of calcium precipitation.
In particular, citrate can bind to nascent hydroxyapatite crystals and prevent their propagation.
Blood citrate levels are greater after dialysis with citrate dialysates than with non-citrate dialysates, which could slow vascular calcification.
However, this has never been investigated.
Prior research has shown that arterial calcification can be easily detected and reliably measured on routine digital mammograms, with sufficient sensitivity to follow progression.
Mammography is more sensitive in detecting arterial calcification than other imaging and associated with far less radiation and cost.
This will allow the researchers to detect differences between citrate and non-citrate dialysates in a safe and convenient way.
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 by mammography every 6 months.
The endpoint will be the difference in the rate of progression of breast arterial calcification (BAC) between dialysis with citrate and non-citrate dialysates.
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: W. Charles O'Neill, MD
- Phone Number: 404-727-3922
- Email: woneill@emory.edu
Study Locations
-
-
Georgia
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Atlanta, Georgia, United States, 30318
- Emory Dialysis at Northside
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Atlanta, Georgia, United States, 30331
- Emory Dialysis at Greenbriar
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Decatur, Georgia, United States, 30033
- Emory Dialysis at North Decatur
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Decatur, Georgia, United States, 30034
- Emory Dialysis at Candler
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- hemodialysis patients with BAC on mammograms
Exclusion Criteria:
- current warfarin use
- severe hyperparathyroidism (likely to undergo parathyroidectomy in the next 2 years)
- difficulty controlling serum calcium (likely to require changes in dialysate calcium concentration in the next 2 years)
- life expectancy < 2 years
- prisoners
- inability to give consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Citrate Dialysate then Standard Dialysate
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.
|
Dialysate is generated during dialysate from two concentrates (acid concentrate and bicarbonate concentrate) mixed with treated water.
When used, citrate is provided in the acid concentrate.
The acid concentrate with citrate is approved for this use by the FDA and will be used according to standard procedures without altered dialysis machine settings.
Other Names:
Dialysate is generated during dialysate from two concentrates (acid concentrate and bicarbonate concentrate) mixed with treated water.
The acid concentrate without citrate is approved for this use by the FDA and will be used according to standard procedures without altered dialysis machine settings.
Other Names:
|
Active Comparator: Standard Dialysate
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.
|
Dialysate is generated during dialysate from two concentrates (acid concentrate and bicarbonate concentrate) mixed with treated water.
When used, citrate is provided in the acid concentrate.
The acid concentrate with citrate is approved for this use by the FDA and will be used according to standard procedures without altered dialysis machine settings.
Other Names:
Dialysate is generated during dialysate from two concentrates (acid concentrate and bicarbonate concentrate) mixed with treated water.
The acid concentrate without citrate is approved for this use by the FDA and will be used according to standard procedures without altered dialysis machine settings.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in rate of progression of breast arterial calcification (BAC)
Time Frame: Baseline, Month 6, Month 12, Month 18, Month 24
|
Rate of BAC progression will be calculated by linear regression of 3 mammograms in each treatment arm (Months 0, 6 and 12 versus Months 12, 18 and 24).
Progression of calcification is quantified as the length of calcified artery segments, measured in millimeters.
|
Baseline, Month 6, Month 12, Month 18, Month 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: W. Charles O'Neill, MD, Emory University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 2, 2021
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
June 30, 2021
First Submitted That Met QC Criteria
June 30, 2021
First Posted (Actual)
July 9, 2021
Study Record Updates
Last Update Posted (Actual)
August 14, 2023
Last Update Submitted That Met QC Criteria
August 8, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00002119
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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