Citrate Dialysis for Vascular Calcification

No longer recruiting at 3 trial locations

Overseen By W. Charles O'Neill, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Emory University

Must not be taking: Warfarin

Disqualifiers: Severe hyperparathyroidism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special dialysis solution with citrate (Citrate Dialysate) can slow the hardening of blood vessels. Participants will use two different dialysis solutions over two years: one with citrate and one without (Standard Dialysate), to assess their effects. Researchers will monitor progress by taking mammograms and blood samples every six months. The trial seeks individuals already on hemodialysis who show specific signs of blood vessel hardening on their mammograms. As an unphased trial, it offers patients the chance to contribute to important research that could enhance future dialysis treatments.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using warfarin.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that citrate dialysate is generally well-tolerated in hemodialysis treatments. One study found that it improved dialysis efficiency and helped maintain stable blood pressure during treatments.

However, some sessions reported issues such as an imbalance of sodium in the blood in 15% of cases and a disturbance in the body's acid-base balance in 9.4% of cases. While important to consider, these issues were not common for most patients.

Overall, evidence suggests citrate dialysate is safe for many people. However, like any treatment, it may not be suitable for everyone. Concerns should be discussed with a healthcare provider to determine if this treatment is appropriate. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using citrate dialysate for vascular calcification because it could offer a safer alternative to standard dialysate. Unlike traditional treatments that use an acidic concentrate, citrate dialysate helps to prevent calcium buildup in blood vessels by binding to calcium more effectively. This could lead to less vascular calcification, a common and dangerous issue for patients undergoing regular dialysis. By potentially reducing this risk, citrate dialysate might improve cardiovascular outcomes for these patients.

What evidence suggests that this trial's treatments could be effective for vascular calcification?

Research has shown that citrate dialysate might help reduce vascular calcification, the hardening of blood vessels. Some studies suggest that citrate can balance calcium levels in the body, potentially slowing this hardening. However, not all research agrees. One study found that citrate increased hardening, while another found no significant change. In this trial, participants will receive either citrate dialysate followed by standard dialysate or standard dialysate followed by citrate dialysate. These findings suggest that while citrate dialysate shows promise, its effect on blood vessel hardening remains uncertain and requires further research. ^{2 4 6 7 8}

Who Is on the Research Team?

W. Charles O'Neill, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for hemodialysis patients who have vascular calcification visible on mammograms. It's not suitable for those with a life expectancy under 2 years, current warfarin users, individuals unable to consent, prisoners, or those with severe hyperparathyroidism or calcium control issues.

Inclusion Criteria

I am on hemodialysis and my mammogram shows breast arterial calcification.

Exclusion Criteria

I am currently taking warfarin.

I am unable to understand and give consent for treatment.

Prisoners

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Participants receive hemodialysis using either a citrate or non-citrate dialysate for 12 months

12 months

Mammograms and blood samples every 6 months

Treatment Phase 2

Participants switch to the alternate dialysate solution for another 12 months

12 months

Mammograms and blood samples every 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Citrate Dialysate
• Standard Dialysate

Trial Overview The study tests if hemodialysis using citrate can slow down the hardening of blood vessels compared to standard dialysis solutions. Participants will use one solution for a year and then switch to the other for another year while their vascular health is monitored.

How Is the Trial Designed?

Group I: Citrate Dialysate then Standard Dialysate Experimental Treatment 2 Interventions

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.

Group II: Standard Dialysate then Citrate Dialysate Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Fresenius Medical Care Renal Therapies Group (FMCRTG)

Collaborator

Trials

1

Recruited

50+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6894765/

Citric-acid dialysate improves the calcification propensity of ... Calcification propensity, as measured by the change in T50, improved significantly during treatment in C1.5 compared to A1.25 and A1.5. Long- ...

2. journals.lww.com journals.lww.com/10.1681/ASN.2024zpqym0r4

Effect of Hemodialysis with Citrate on Vascular Calcification Conclusion: Citrate HD unexpectedly promoted vascular calcification, which was not explained by changes in mineral metabolism or dialysis adequacy. This result ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07163936

Analysis of the Influence of Dialysis Fluid Composition on ... Citrate is a promising substitute that may help reduce vascular calcification by maintaining a neutral calcium balance. Nevertheless, it can ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2468024924016085

Citrate-Buffered, Magnesium-Enriched Dialysate on ... Discussion. The main finding of our study is that there was no difference in calcification propensity of serum as measured using the T50 test between patients ...

5. nature.com nature.com/articles/s41598-019-47934-7

Impact of acetate- or citrate-acidified bicarbonate dialysate ... Citrate has been shown to inhibit calcification in urine in hemodialysis patients. Therefore, our hypothesis is that citrate-acidified ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8791321/

Citric Acid–Containing Dialysate and Survival Rate in the ... Citric acid–containing dialysate might improve dialysis efficiency, anticoagulation, calcification propensity score, and intradialytic hemodynamic stability.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10691098/

Quality indicators in prolonged hemodialysis with regional ... Evaluated safety indicators were dysnatremia and metabolic alkalosis, observed in 15% and 9.4% of the sessions, respectively. Indicators of ...

8. academic.oup.com academic.oup.com/ckj/article/17/10/sfae288/7811320

effects of dialysate calcium prescription on mortality outcomes ... Adjusted risk of sudden cardiac death was lower for dialysate calcium 1.50 mmol/l (HR 0.81, 95% CI 0.67–0.97). Significant and positive ...