An interventional study of Citrate Dialysate and Standard Dialysate in Vascular Calcification, sponsored by Emory University. Completed at 4 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by Emory University · Not applicable, Interventional, and Supportive care
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.
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.
82 studies on the registry are indexed under Vascular Calcification; 17 are open to participants now.
This study's enrollment of 54 is below the median of 64 across 56 interventional studies indexed under Vascular Calcification.
Browse Vascular Calcification studies →Emory University is the lead sponsor of 1,405 studies on the registry; 225 are open to participants now.
Of its 237 completed or terminated interventional studies of FDA-regulated products, 178 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Citrate Dialysate · Device: 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.
Device: Citrate Dialysate · Device: Standard Dialysate
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.
Also known as: Citrasate
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.
Also known as: Naturalyte
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.
Time frame: 3 measurements during 12 months of treatment for each study period (up to 24 months for both years of the study)
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.
Time frame: 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.
Time frame: 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.
Time frame: Pre-HD and Post-HD during each study period (up to 24 months for both years of the study)
The first individual gave informed consent to participate on May 27, 2021 and all study follow up was complete by March 18, 2025. Participants were enrolled from Emory Dialysis centers in Atlanta and Decatur, Georgia, USA.
| Milestone | Citrate Dialysate Then Standard Dialysate | Standard Dialysate Then Citrate Dialysate |
|---|---|---|
| Started | 29 | 25 |
| Completed | 17 | 17 |
| Not completed | 12 | 8 |
| Withdrew: Death | 2 | 4 |
| Withdrew: Lost to follow-up | 5 | 2 |
| Withdrew: Physician decision | 3 | 1 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Milestone | Citrate Dialysate Then Standard Dialysate | Standard Dialysate Then Citrate Dialysate |
|---|---|---|
| Started | 17 | 17 |
| Completed | 16 | 13 |
| Not completed | 1 | 4 |
| Withdrew: Death | 1 | 1 |
| Withdrew: Lost to follow-up | 0 | 2 |
| Withdrew: Withdrawal by subject | 0 | 1 |
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.
| millimeters (mm) per year | Citrate Dialysate | Standard Dialysate |
|---|---|---|
| Length of Calcified Artery Segments | 47 (10 to 124) | 9 (-4 to 34) |
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.
| mg/dL | Citrate Dialysate | Standard Dialysate |
|---|---|---|
| Pre-HD | 4.8 ± 0.07 | 4.8 ± 0.10 |
| Post-HD | 4.6 ± 0.04 | 4.9 ± 0.08 |
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.
| mg/dL | Citrate Dialysate | Standard Dialysate |
|---|---|---|
| Pre-HD | 2.3 ± 0.04 | 2.4 ± 0.07 |
| Post-HD | 2.0 ± 0.02 | 2.1 ± 0.03 |
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.
| micrometer (uM) | Citrate Dialysate | Standard Dialysate |
|---|---|---|
| Pre-HD | 134 ± 9 | 130 ± 7 |
| Post-HD | 383 ± 16 | 187 ± 20 |
Collected over Information on adverse events was collected beginning at the start of the study intervention and continued through the final assessment at Month 24 (up to 24 months).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Citrate Dialysate | 3/54 (5.6%) | 0/54 (0%) | 0/54 (0%) |
| Standard Dialysate | 5/54 (9.3%) | 0/54 (0%) | 0/54 (0%) |
| Age, Categorical(Participants) | Citrate Dialysate Then Standard Dialysate | Standard Dialysate Then Citrate Dialysate | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 22 | 18 | 40 |
| >=65 years | 7 | 7 | 14 |
| Age, Continuous(years) | Citrate Dialysate Then Standard Dialysate | Standard Dialysate Then Citrate Dialysate | Total |
|---|---|---|---|
| Mean | 56.4 ± 9.5 | 59.8 ± 11.3 | 58.0 ± 10.4 |
| Sex: Female, Male(Participants) | Citrate Dialysate Then Standard Dialysate | Standard Dialysate Then Citrate Dialysate | Total |
|---|---|---|---|
| Female | 29 | 25 | 54 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Citrate Dialysate Then Standard Dialysate | Standard Dialysate Then Citrate Dialysate | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 29 | 25 | 54 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Citrate Dialysate Then Standard Dialysate | Standard Dialysate Then Citrate Dialysate | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 29 | 25 | 54 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Citrate Dialysate Then Standard Dialysate | Standard Dialysate Then Citrate Dialysate | Total |
|---|---|---|---|
| United States | 29 | 25 | 54 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified individual participant data collected during this trial may be made available for sharing with other researchers.
Supporting information: Study protocol
Time frame: Sharing will begin after publication of results from this study.
Access criteria: Individual participant data will be made available to researchers who provide a methodologically sound proposal in order to achieve aims in the approved proposal. Proposals should be directed to Dr. O'Neill at woneill@emory.edu.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.