Vascular CalcificationCalCio-HDNCT07163936
Analysis of the Influence of Dialysis Fluid Composition on Vascular Calcification in Patients With Chronic Kidney Disease Undergoing Hemodialysis
A study testing Citrate dialysate with magensium supplementation and Acetate dialysate in people with Vascular Calcification and Hemodialysis, run by Hospital Clinic of Barcelona.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Calcification, Hemodialysis, Cardiovascular Disease (CKD)
- What is being tested?
- Citrate dialysate with magensium supplementation and Acetate dialysate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2027to 2 Jan 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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:
Read more
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
Read the detailed description
Vascular calcification is a common and serious complication in patients receiving long-term hemodialysis. Dialysate composition may influence its progression. Acetate, a weak acid, has traditionally been added to dialysate to maintain chemical stability and prevent precipitation of calcium or magnesium bicarbonate salts. However, long-term acetate exposure has been associated with adverse effects, prompting the search for safer alternatives.
Citrate is a promising substitute that may help reduce vascular calcification by maintaining a neutral calcium balance. Nevertheless, it can lower magnesium levels in the blood (hypomagnesemia), which might counteract its benefits. This supports the idea of adding magnesium to citrate-based dialysate.
This is a prospective, randomized, open-label clinical trial designed to compare the effects of acetate-based dialysate versus citrate-based dialysate with magnesium supplementation in adult hemodialysis patients. Participants will be enrolled and followed for 12 months.
The primary outcome will be changes in calcification propensity (T50). Secondary outcomes include changes in serum magnesium, calcium, and PTH levels, as well as the incidence of cardiovascular events and all-cause mortality.
The findings may help identify a safer and more effective dialysate composition to improve cardiovascular outcomes in this patient population.
- Being tested
- Citrate dialysate with magensium supplementation, Acetate dialysate
- Keywords
- hemodialysis, dialysate, citrate dialysate, acetate dialysate, magnesium supplementation, calcification propensity, vascular calcification, dialysate composition
- Medical subject headings
- Vascular Calcification, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citrate dialysate with magensium supplementationDevice
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.
Acetate dialysateDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Acetate dialysate | Active comparator | Fresenius SmartBag 211.5 Receives: Device: Acetate dialysate |
| Citrate dialysate | Experimental | Fresenius SmartBag CA 211.5-0.75 Receives: Device: Citrate dialysate with magensium supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and at 3, 6, 9, and 12 months
Secondary outcomes (4)
Serum magnesium levels
Measurement of total serum magnesium to assess electrolyte balance and detect hypomagnesemia or hypermagnesemia during the intervention.
Measured: Baseline and at 3, 6, 9, and 12 months
Total serum calcium levels
Measurement of total calcium to monitor mineral metabolism and calcium homeostasis.
Measured: Baseline and at 3, 6, 9, and 12 months
Parathyroid hormone (PTH) levels
Measurement of intact parathyroid hormone to assess bone-mineral metabolism and response to dialysate composition.
Measured: Baseline and at 3, 6, 9, and 12 months
Serum vitamin D levels
Measurement of serum 25-hydroxyvitamin D to evaluate vitamin D status and its potential influence on mineral metabolism.
Measured: Baseline and at 3, 6, 9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start2 Jan 2027 (estimated)
- Primary completion2 Jan 2028 (estimated)
- Study completion2 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular CalcificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163936
- Sponsor's protocol ID
- HCB/2024/0318
- Acronym
- CalCio-HD
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD including de-identified laboratory results, demographic and clinical variables, and primary and secondary outcome data will be shared. Data will be anonymized to protect patient confidentiality.