Effect of Citrate Dialysate on Vascular Calcification

NCT04956120 | Completed Results FDA Device

• 1 other identifier: STUDY00002119
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 4

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.

Conditions

Vascular Calcification

Keywords

Hemodialysis; Breast arterial calcification

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (3)

• Serum Ionized Calcium (iCa)

  Pre-HD and Post-HD during each study period (up to 24 months for both years of the study)

• Serum Magnesium (Mg)

  Pre-HD and Post-HD during each study period (up to 24 months for both years of the study)

• Plasma Citrate

  Pre-HD and Post-HD during each study period (up to 24 months for both years of the study)

Study Arms (2)

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.

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.

Device: Citrate Dialysate; Device: Standard Dialysate

Interventions

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.

Also known as: Citrasate

Citrate Dialysate then Standard Dialysate; Standard Dialysate then Citrate Dialysate

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.

Also known as: Naturalyte

Citrate Dialysate then Standard Dialysate; Standard Dialysate then Citrate Dialysate

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• hemodialysis patients with BAC on mammograms

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Fresenius Medical Care Renal Therapies Group (FMCRTG): collaborator

Study Sites (4)

Emory Dialysis at Northside

Atlanta, Georgia, 30318, United States

Location

Emory Dialysis at Greenbriar

Atlanta, Georgia, 30331, United States

Location

Emory Dialysis at North Decatur

Decatur, Georgia, 30033, United States

Location

Emory Dialysis at Candler

Decatur, Georgia, 30034, United States

Location

MeSH Terms

Conditions

Vascular Calcification

Condition Hierarchy (Ancestors)

Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: W. Charles O'Neill, MD
• Organization: Emory University

woneill@emory.edu

404-727-3922

Study Officials

• W. Charles O'Neill, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 9, 2021
• Study Start: May 27, 2021
• Primary Completion: March 18, 2025
• Study Completion: March 18, 2025
• Last Updated: May 5, 2026
• Results First Posted: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (4)