Effect of Citrate Dialysis on Vascular Calcification

Vascular Calcification Clinical Trial

Official title:

Effect of Citrate Dialysate on Vascular Calcification

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04956120
• Other study ID #: STUDY00002119
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2, 2021
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Calcinosis
• Vascular Calcification

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Emory Dialysis at Greenbriar	Atlanta	Georgia
United States	Emory Dialysis at Northside	Atlanta	Georgia
United States	Emory Dialysis at Candler	Decatur	Georgia
United States	Emory Dialysis at North Decatur	Decatur	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Fresenius Medical Care Renal Therapies Group (FMCRTG)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Month 6, Month 12, Month 18, Month 24