Effect of Citrate Dialysis on Vascular Calcification
Primary Purpose
Vascular Calcification
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Citrate Dialysate
Standard Dialysate
Sponsored by
About this trial
This is an interventional supportive care trial for Vascular Calcification focused on measuring Hemodialysis, Breast arterial calcification
Eligibility Criteria
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
Sites / Locations
- Emory Dialysis at Northside
- Emory Dialysis at Greenbriar
- Emory Dialysis at North Decatur
- Emory Dialysis at Candler
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Citrate Dialysate then Standard Dialysate
Standard Dialysate
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in rate of progression of breast arterial calcification (BAC)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04956120
First Posted
June 30, 2021
Last Updated
August 8, 2023
Sponsor
Emory University
Collaborators
Fresenius Medical Care Renal Therapies Group (FMCRTG)
1. Study Identification
Unique Protocol Identification Number
NCT04956120
Brief Title
Effect of Citrate Dialysis on Vascular Calcification
Official Title
Effect of Citrate Dialysate on Vascular Calcification
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Fresenius Medical Care Renal Therapies Group (FMCRTG)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Calcification
Keywords
Hemodialysis, Breast arterial calcification
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Citrate Dialysate then Standard Dialysate
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Dialysate
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Citrate Dialysate
Other Intervention Name(s)
Citrasate
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Standard Dialysate
Other Intervention Name(s)
Naturalyte
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in rate of progression of breast arterial calcification (BAC)
Description
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.
Time Frame
Baseline, Month 6, Month 12, Month 18, Month 24
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
W. Charles O'Neill, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory Dialysis at Northside
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Emory Dialysis at Greenbriar
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Emory Dialysis at North Decatur
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Emory Dialysis at Candler
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30034
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Citrate Dialysis on Vascular Calcification
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