Analysis of the Influence of Dialysis Fluid Composition on Vascular Calcification in Patients With Chronic Kidney Disease Undergoing Hemodialysis

NCT07163936 | Not Yet Recruiting

• 1 other identifier: HCB/2024/0318
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to find out if using a citrate-based dialysate with added magnesium during hemodialysis can help slow down or prevent the hardening of blood vessels (vascular calcification) in adults on long-term dialysis. The main questions the study will try to answer are: Does citrate-based dialysate with magnesium improve the blood's ability to prevent calcium buildup (measured by a test called T50) compared to acetate-based dialysate? Does it modify magnesium, calcium and parathyroid hormone (PTH) levels in the blood? Does it lower the chances of heart problems or death? Researchers will compare two groups: one will receive acetate-based dialysate, and the other will receive citrate-based dialysate with magnesium. Participants will: Receive one of the two types of dialysate during their regular hemodialysis sessions for 12 months Have regular blood tests Be monitored for any heart problems and for overall health during the study

Conditions

Vascular Calcification; Hemodialysis; Cardiovascular Disease (CKD)

Keywords

hemodialysis; dialysate; citrate dialysate; acetate dialysate; magnesium supplementation; calcification propensity; vascular calcification; dialysate composition

Outcome Measures

Primary Outcomes (1)

• Calcification propensity (T50 test)

  T50 is a laboratory test that measures the serum's intrinsic capacity to inhibit calcium-phosphate precipitation, reflecting the overall propensity for vascular and soft tissue calcification. Higher T50 values indicate greater calcification resistance.

  Baseline and at 3, 6, 9, and 12 months

Secondary Outcomes (4)

• Serum magnesium levels

  Baseline and at 3, 6, 9, and 12 months

• Total serum calcium levels

  Baseline and at 3, 6, 9, and 12 months

• Parathyroid hormone (PTH) levels

  Baseline and at 3, 6, 9, and 12 months

• Serum vitamin D levels

  Baseline and at 3, 6, 9, and 12 months

Other Outcomes (1)

• Cardiovascular events and all-cause mortality

  During the 12-month follow-up period

Study Arms (2)

Acetate dialysate

ACTIVE COMPARATOR

Fresenius SmartBag 211.5

Device: Acetate dialysate

Citrate dialysate

EXPERIMENTAL

Fresenius SmartBag CA 211.5-0.75

Device: Citrate dialysate with magensium supplementation

Interventions

Citrate dialysate with magensium supplementation DEVICE

Citrate-based bicarbonate dialysate containing: sodium 138 mmol/L, chloride 110 mmol/L, potassium 2 mmol/L, calcium 1.5 mmol/L, magnesium 0.75 mmol/L, citrate 1 mmol/L, glucose 1 g/L, bicarbonate 32 mmol/L.

Citrate dialysate

Acetate dialysate DEVICE

Acetate-based bicarbonate dialysate containing: sodium 138 mmol/L, chloride 109 mmol/L, potassium 2 mmol/L, calcium 1.5 mmol/L, magnesium 0.5 mmol/L, acetate 3 mmol/L, glucose 1 g/L, bicarbonate 32 mmol/L.

Acetate dialysate

Eligibility Criteria

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

You may qualify if:

• Adults (≥18 years old) on maintenance hemodialysis for more than 3 months
• Clinically stable patients with a well-functioning vascular access
• Residual urine output ≤ 250 mL/day
• Able and willing to provide written informed consent

You may not qualify if:

• Known allergy or intolerance to any component of the dialysates
• Active malignancy or infectious/inflammatory disease
• Planned living donor kidney transplant before study completion
• Current treatment with vitamin K antagonists (coumarins)
• Severe hypocalcemia or poorly controlled secondary hyperparathyroidism
• Any condition that, in the investigator's judgment, contraindicates participation or affects study compliance

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

MeSH Terms

Conditions

Vascular Calcification; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jose Jesus Broseta Monzo, MD, PhD

CONTACT

(+34)932275400; jjbroseta@clinic.cat

Francisco Maduell Canals, MD, PhD

CONTACT

(+34)932275400; fmaduell@clinic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, randomized, open-label, single-center clinical trial with 12 months of follow-up. Participants will be randomly assigned in a 1:1 ratio to one of two study arms: Control group: Hemodialysis with acetate-based dialysate (Fresenius SmartBag 211.5) Intervention group: Hemodialysis with citrate-based dialysate containing magnesium supplementation (Fresenius SmartBag CA 211.5-0.75) Both dialysates are routinely used in clinical practice.

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 9, 2025
• Study Start: September 3, 2025
• Primary Completion (Estimated): September 6, 2026
• Study Completion (Estimated): September 6, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available starting from the date of study results publication and will remain accessible indefinitely.
• Access Criteria: De-identified individual participant data and supporting documents will be made publicly available on a GitHub repository. Researchers and the public can access and download the data freely without restriction. Data will be anonymized to protect participant confidentiality. Users will be encouraged to cite the original study when using the data.