End Stage Renal DiseaseNCT07663279
BicMag Study - Improving Mineral Buffering Capacity in Dialysis Patients
A study testing D-Standard, D-Bic and D-Mag in people with End Stage Renal Disease, run by Elisabethinen Hospital.
Trial summary
The BicMag study is a prospective, randomized, controlled cross-over study that aims to examine the potential additive effect of a dialysate enriched with both bicarbonate and magnesium on mineral buffering capacity in the blood of chronic hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- D-Standard, D-Bic and D-Mag
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years
- Prevalent patients (≥ 3 months) treated with thrice weekly hemodialysis or hemodiafiltration
- Dialysate calcium of 1.25 mmol/l
Who cannot join
- Inability to provide informed consent
- Currently participating in another investigational device or drug study or non-interventional study
- Dialysate calcium other than 1.25 mmol/l
- Parathyroidectomy planned during the study
- Elective living-donor kidney transplant scheduled during the study period
- Therapy with bisphosphonates within the past 12 months or denosumab within the past 6 months
- Pregnant or nursing (lactating) women
About this study
The BicMag study is a prospective, randomized, controlled cross-over study that aims to examine the potential additive effect of a dialysate enriched with both bicarbonate and magnesium on mineral buffering capacity in the blood of chronic hemodialysis patients.
Read the detailed description
We hypothesize that simultaneously increasing bicarbonate and magnesium concentrations in the dialysate will enhance mineral buffering capacity more effectively than either intervention alone. Ninty-one chronic hemodialysis patients will be enrolled in this randomized, controlled, cross-over study. Using a balanced Latin square design, participants will undergo four sequential 3-week treatment phases with the following dialysates:
- D-Standard: 32 mmol/L bicarbonate, 0.5 mmol/L magnesium
- D-Bic: 37 mmol/L bicarbonate, 0.5 mmol/L magnesium
- D-Mag: 32 mmol/L bicarbonate, 1 mmol/L magnesium
- D-BicMag: 37 mmol/L bicarbonate, 1 mmol/L magnesium. The primary endpoint is calciprotein crystallization time (T50); the secondary endpoint is serum levels of endogenous calciprotein particles.
- Conditions
- End Stage Renal Disease
- Being tested
- D-Standard, D-Bic, D-Mag, D-BicMag
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-StandardOther
Center's standard dialysate containing 32 mmol/L bicarbonate and 0.5 mmol/L magnesium
D-BicOther
Dialysate bicarbonate increased to 37 mmol/L; dialysate magnesium held at 0.5 mmol/L
D-MagOther
Dialysate magnesium increased to 1.0 mmol/L; dialysate bicarbonate held at 32 mmol/L
D-BicMagOther
Dialysate bicarbonate increased to 37 mmol/L; dialysate magnesium increased to 1.0 mmol/L
| Study group | Role | What they receive |
|---|---|---|
| dialysate composition adjustment | Experimental | Four sequential 3-week treatment periods with different dialysate compositions (D-Standard, D-Bic, D-Mag, D-BicMag) in a crossover design. Receives: Other: D-Standard; Other: D-Bic; Other: D-Mag; Other: D-BicMag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calciprotein crystallization time (T50) as a measure of mineral buffering capacity
Intra-individual difference in T50 between the combination dialysate (D-BicMag) and each of the single-intervention dialysates (D-Bic and D-Mag)
Measured: 3 weeks (per study phase)
Secondary outcomes (1)
Endogenous calciprotein particle (CPP) levels
Intra-individual difference in endogenous calciprotein particle levels between the combination dialysate (D-BicMag) and each of the single-intervention dialysates (D-Bic and D-Mag)
Measured: 3 weeks (per study phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 91 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elisabethinen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prim. Priv. Doz. Dr. Daniel Cejka, Elisabethinen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07663279
- Sponsor's protocol ID
- BicMag-HD-T50
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BicMag Study - Improving Mineral Buffering Capacity in Dialysis Patients
- ClinicalTrials.gov ID
- NCT07663279
- Acronym / sponsor ID
- BicMag-HD-T50
- Conditions
- End Stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 91 participants (estimated)
- Lead sponsor
- Elisabethinen HospitalUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 23 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The BicMag study is a prospective, randomized, controlled cross-over study that aims to examine the potential additive effect of a dialysate enriched with both bicarbonate and magnesium on mineral buffering capacity in the blood of chronic hemodialysis patients.
Detailed description
We hypothesize that simultaneously increasing bicarbonate and magnesium concentrations in the dialysate will enhance mineral buffering capacity more effectively than either intervention alone. Ninty-one chronic hemodialysis patients will be enrolled in this randomized, controlled, cross-over study. Using a balanced Latin square design, participants will undergo four sequential 3-week treatment phases with the following dialysates:
- D-Standard: 32 mmol/L bicarbonate, 0.5 mmol/L magnesium
- D-Bic: 37 mmol/L bicarbonate, 0.5 mmol/L magnesium
- D-Mag: 32 mmol/L bicarbonate, 1 mmol/L magnesium
- D-BicMag: 37 mmol/L bicarbonate, 1 mmol/L magnesium. The primary endpoint is calciprotein crystallization time (T50); the secondary endpoint is serum levels of endogenous calciprotein particles.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dialysate composition adjustment | Experimental | Other: D-Standard, Other: D-Bic, Other: D-Mag, Other: D-BicMagFour sequential 3-week treatment periods with different dialysate compositions (D-Standard, D-Bic, D-Mag, D-BicMag) in a crossover design. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Prevalent patients (≥ 3 months) treated with thrice weekly hemodialysis or hemodiafiltration
- Dialysate calcium of 1.25 mmol/l
Key exclusion criteria (7 listed)
- Inability to provide informed consent
- Currently participating in another investigational device or drug study or non-interventional study
- Dialysate calcium other than 1.25 mmol/l
- Parathyroidectomy planned during the study
- Elective living-donor kidney transplant scheduled during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-StandardCenter's standard dialysate containing 32 mmol/L bicarbonate and 0.5 mmol/L magnesium | Other | dialysate composition adjustment |
| D-BicDialysate bicarbonate increased to 37 mmol/L; dialysate magnesium held at 0.5 mmol/L | Other | dialysate composition adjustment |
| D-MagDialysate magnesium increased to 1.0 mmol/L; dialysate bicarbonate held at 32 mmol/L | Other | dialysate composition adjustment |
| D-BicMagDialysate bicarbonate increased to 37 mmol/L; dialysate magnesium increased to 1.0 mmol/L | Other | dialysate composition adjustment |
Primary outcome
Calciprotein crystallization time (T50) as a measure of mineral buffering capacity
Time frame: 3 weeks (per study phase)
Intra-individual difference in T50 between the combination dialysate (D-BicMag) and each of the single-intervention dialysates (D-Bic and D-Mag)
1 secondary outcome
Endogenous calciprotein particle (CPP) levels
Time frame: 3 weeks (per study phase)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing D-Standard, D-Bic and D-Mag in people with End Stage Renal Disease, run by Elisabethinen Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calciprotein crystallization time (T50) as a measure of mineral buffering capacity (time frame: 3 weeks (per study phase)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.