Effect of Citrate Dialysate on Vascular Calcification

Not Applicable

Completed

• Conditions: Vascular Calcification
• Interventions: Device: Citrate Dialysate; Device: Standard Dialysate

• Registration Number: NCT04956120
• Lead Sponsor: Emory University

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.

Study Timeline

• Study Start: 2021-06-02
• Study First Submitted: 2021-06-30
• Study First Submitted QC: 2021-06-30
• Study First Posted: 2021-07-09
• Primary Completion: 2025-03-18
• Study Completion: 2025-03-18
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Citrate Dialysate then Standard Dialysate	Citrate 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.
Standard Dialysate	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.
Standard Dialysate	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.
Citrate Dialysate then Standard Dialysate	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.

Primary Outcome Measures

Name	Time	Method
Length of Calcified Artery Segments	Month 0 (baseline), Month 6, Month 12, Month 18, Month 24	Rate of progression of breast arterial calcification (BAC) is 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.

Trial Locations

Locations (4)

Emory Dialysis at Northside; 🇺🇸 Atlanta, Georgia, United States

Emory Dialysis at North Decatur; 🇺🇸 Decatur, Georgia, United States

Emory Dialysis at Candler; 🇺🇸 Decatur, Georgia, United States

Emory Dialysis at Greenbriar; 🇺🇸 Atlanta, Georgia, United States