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| Name | Class |
|---|---|
| Fresenius Medical Care Renal Therapies Group (FMCRTG) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Citrate Dialysate | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 measurements during 12 months of treatment for each study period (up to 24 months for both years of the study) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-HD and Post-HD during each study period (up to 24 months for both years of the study) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| W. Charles O'Neill, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Dialysis at Northside | Atlanta | Georgia | 30318 | United States | ||
| Emory Dialysis at Greenbriar |
De-identified individual participant data collected during this trial may be made available for sharing with other researchers.
Sharing will begin after publication of results from this study.
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.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Citrate 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. Standard Dialysate: 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. |
| FG001 | Standard Dialysate Then Citrate 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. Citrate 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. Standard Dialysate: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First year of study |
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| Second year of study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | This analysis includes participants who completed both years of the study. One participant was excluded from due to the mammograms having inconsistent breast coverage resulting in the scans not being adequate for measurement of breast arterial calcification (BAC), providing a sample size of 28 participants for analysis. | Posted | Median | Inter-Quartile Range | millimeters (mm) per year | 3 measurements during 12 months of treatment for each study period (up to 24 months for both years of the study) |
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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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Citrate Dialysate | Participants receiving hemodialysis using a citrate acid concentrate dialysate during the first year of the study or the second year of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| W. Charles O'Neill, MD | Emory University | 404-727-3922 | woneill@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 6, 2022 | Feb 25, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D061205 | Vascular Calcification |
| ID | Term |
|---|---|
| D002114 | Calcinosis |
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
|
| Standard Dialysate | Device | 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. |
|
|
| 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. | 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. | Pre-HD and Post-HD during each study period (up to 24 months for both years of the study) |
| Atlanta |
| Georgia |
| 30331 |
| United States |
| Emory Dialysis at North Decatur | Decatur | Georgia | 30033 | United States |
| Emory Dialysis at Candler | Decatur | Georgia | 30034 | United States |
| Physician Decision |
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| Protocol Violation |
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| Withdrawal by Subject |
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| NOT COMPLETED |
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| Standard Dialysate Then Citrate 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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Participants receiving hemodialysis using a citrate acid concentrate dialysate during the first year of the study, or the second year of the study. |
| OG001 | Standard Dialysate | Participants receiving hemodialysis using a non-citrate acid concentrate dialysate for the first year of the study, or the second year of the study. |
|
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| Secondary | 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. | This analysis includes participants completing both years of the study. One participant was excluded from due to the mammograms having inconsistent breast coverage resulting in the scans not being adequate for measurement of BAC, providing a sample size of 28 participants for analysis. Post-dialysis serum iCa was not measured in one participant during the citrate arm. During the standard dialysate arm, pre-dialysis serum iCa was missing on one participant, post-dialysis iCa on two participants. | Posted | Mean | Standard Error | mg/dL | Pre-HD and Post-HD during each study period (up to 24 months for both years of the study) |
|
|
|
| Secondary | 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. | This analysis includes participants completing both years of the study. One participant was excluded from due to the mammograms having inconsistent breast coverage resulting in the scans not being adequate for measurement of BAC, providing a sample size of 28 participants for analysis. Both pre-dialysis and post-dialysis serum Mg are missing for two participants during the standard dialysate arm. | Posted | Mean | Standard Error | mg/dL | Pre-HD and Post-HD during each study period (up to 24 months for both years of the study) |
|
|
|
| Secondary | 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. | This analysis includes participants completing both years of the study. One participant was excluded from due to the mammograms having inconsistent breast coverage resulting in the scans not being adequate for measurement of BAC, providing a sample size of 28 participants for analysis. Plasma citrate was not measured in 3 participants who were at the furthest outlying dialysis center, due to logistical issues. | Posted | Mean | Standard Error | micrometer (uM) | Pre-HD and Post-HD during each study period (up to 24 months for both years of the study) |
|
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|
| 3 |
| 54 |
| 0 |
| 54 |
| 0 |
| 54 |
| EG001 | Standard Dialysate | Participants receiving hemodialysis using a non-citrate acid concentrate dialysate for the first year of the study or the second year of the study. | 5 | 54 | 0 | 54 | 0 | 54 |
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| Post-HD |
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