Vascular CalcificationNCT04956120
Effect of Citrate Dialysate on Vascular Calcification
A study testing Citrate Dialysate and Standard Dialysate in people with Vascular Calcification, run by Emory University at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vascular Calcification
- What is being tested?
- Citrate Dialysate and Standard Dialysate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 4 sitesUnited States
- Study dates
- 27 May 2021to 18 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hemodialysis patients with BAC on mammograms
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Emory Dialysis at Northside
Atlanta, Georgia, 30318
Emory Dialysis at Greenbriar
Atlanta, Georgia, 30331
Emory Dialysis at North Decatur
Decatur, Georgia, 30033
Emory Dialysis at Candler
Decatur, Georgia, 30034
About this study
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.
Read the 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.
- Conditions
- Vascular Calcification
- Being tested
- Citrate Dialysate, Standard Dialysate
- Keywords
- Hemodialysis, Breast arterial calcification
- Medical subject headings
- Vascular Calcification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citrate DialysateDevice
Also called Citrasate
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.
Standard DialysateDevice
Also called Naturalyte
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.
| Study group | Role | What they receive |
|---|---|---|
| Citrate Dialysate then Standard Dialysate | Experimental | 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. Receives: Device: Citrate Dialysate; Device: Standard Dialysate |
| Standard Dialysate then Citrate Dialysate | Active comparator | 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. Receives: Device: Citrate Dialysate; Device: Standard Dialysate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Calcified Artery Segments
Rate of progression of breast arterial calcification (BAC) is calculated by linear regression of 3 mammograms over one year 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 per year, measured in millimeters. Slower progression of vascular calcification, indicated by lower values, is a desirable outcome.
Measured: 3 measurements during 12 months of treatment for each study period (up to 24 months for both years of the study)
Secondary outcomes (3)
Serum Ionized Calcium (iCa)
Blood samples were drawn to assess mineral metabolism prior to hemodialysis (HD) and after HD. The values are the mean milligrams (mg) of ionized calcium per deciliter (dL) of blood from two measurements during each study period.
Measured: Pre-HD and Post-HD during each study period (up to 24 months for both years of the study)
Serum Magnesium (Mg)
Blood samples were drawn to assess mineral metabolism prior to and after hemodialysis (HD). The values are mean milligrams (mg) of magnesium per deciliter (dL) of blood from two measurements during each study period.
Measured: Pre-HD and Post-HD during each study period (up to 24 months for both years of the study)
Plasma Citrate
Blood samples were drawn to assess mineral metabolism prior to hemodialysis (HD) and after HD. The values are the mean from two measurements during each study period.
Measured: Pre-HD and Post-HD during each study period (up to 24 months for both years of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start27 May 2021
- Primary completion18 Mar 2025
- Study completion18 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vascular CalcificationStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius Medical Care Renal Therapies Group (FMCRTG)
- Responsible party
- Principal investigator, Charles O'Neill, Emory University
- Investigators
- W. Charles O'Neill, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956120
- Sponsor's protocol ID
- STUDY00002119
- Status last verified
- Apr 2026
- First submitted
- 30 Jun 2021
- Last updated
- 5 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified individual participant data collected during this trial may be made available for sharing with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Citrate Dialysate on Vascular Calcification
- ClinicalTrials.gov ID
- NCT04956120
- Acronym / sponsor ID
- STUDY00002119
- Conditions
- Vascular Calcification
- Keywords
- Hemodialysis, Breast arterial calcification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Fresenius Medical Care Renal Therapies Group (FMCRTG)
- Study start
- 27 May 2021 (actual)
- Primary completion
- 18 Mar 2025 (actual)
- Study completion
- 18 Mar 2025 (actual)
- First posted
- 9 Jul 2021 (actual)
- Results
- Posted 5 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Citrate Dialysate then Standard Dialysate | Experimental | Device: Citrate Dialysate, Device: Standard DialysateParticipants 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. |
| Standard Dialysate then Citrate Dialysate | Active comparator | Device: Citrate Dialysate, Device: Standard DialysateParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- hemodialysis patients with BAC on mammograms
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Citrate DialysateAlso: CitrasateDialysate 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. | Device | Citrate Dialysate then Standard Dialysate, Standard Dialysate then Citrate Dialysate |
| Standard DialysateAlso: NaturalyteDialysate 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. | Device | Citrate Dialysate then Standard Dialysate, Standard Dialysate then Citrate Dialysate |
Primary outcome
Length of Calcified Artery Segments
Time frame: 3 measurements during 12 months of treatment for each study period (up to 24 months for both years of the study)
Rate of progression of breast arterial calcification (BAC) is calculated by linear regression of 3 mammograms over one year 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 per year, measured in millimeters. Slower progression of vascular calcification, indicated by lower values, is a desirable outcome.
3 secondary outcomes
Serum Ionized Calcium (iCa)
Time frame: Pre-HD and Post-HD during each study period (up to 24 months for both years of the study)
Serum Magnesium (Mg)
Time frame: Pre-HD and Post-HD during each study period (up to 24 months for both years of the study)
Plasma Citrate
Time frame: Pre-HD and Post-HD during each study period (up to 24 months for both years of the study)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified individual participant data collected during this trial may be made available for sharing with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
W. Charles O'Neill, MD principal investigator
Emory University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Citrate Dialysate and Standard Dialysate in people with Vascular Calcification, run by Emory University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Calcified Artery Segments (time frame: 3 measurements during 12 months of treatment for each study period (up to 24 months for both years of the study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.