Vascular DiseaseHEMOcalcNCT07170761
Biomarkers and Event Patterns of Vascular Disease in Hemodialysis
An observational study of Vascular Disease and CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder, run by Medical University of Graz at 1 site in Austria.
Trial summary
Parathyroid hormone (PTH) remains the central biomarker to classify CKD-metabolic bone disease (CKD-MBD) in hemodialysis patients. While PTH-values are known to be associated with adverse outcomes, interventional studies have failed to show a benefit of pharmacological modulation of PTH levels on hard clinical… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Vascular Disease, CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder
- How many people
- 475 participants
- Where
- 1 siteAustria
- Study dates
- 15 Oct 2022to 31 Dec 2027
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Prevalent, chronic hemodialysis patients
Who may be able to join
- Stable hemodialysis > 3 months duration
Who cannot join
- Pregnancy
- Acute infections or antibiotic treatment (within 4 weeks)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cross-sectional Biomarker Study for Vascular Calcification in Hemodialysis Patients
Parathyroid hormone (PTH) remains the central biomarker to classify CKD-metabolic bone disease (CKD-MBD) in hemodialysis patients. While PTH-values are known to be associated with adverse outcomes, interventional studies have failed to show a benefit of pharmacological modulation of PTH levels on hard clinical outcomes. To address this gap, the investigators explored alternative markers of bone metabolism, vascular calcification and inflammation in association to prospective event patterns.
- Medical subject headings
- Vascular Diseases, Chronic Kidney Disease-Mineral and Bone Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
All-causes, the date of death will be recorded.
Measured: 1, 2 and 3 years
Secondary outcomes (7)
Cause-specific mortality
The cause of death will be recorded.
Measured: 1, 2 and 3 years
MACE
The number of participants with, the date and cause of MACE (The 4-point MACE is a composite outcome measure of non-fatal stroke and myocardial infarction, urgent angina and fatal cardiovascular events) will be recorded from medical record review.
Measured: 1, 2 and 3 years
The number of participants with hospitalisation for Infection
The number and dates of hospitalisations for any infectious diseases (such as pneumonia, sepsis or urinary tract infection) will be recorded from medical record review.
Measured: 1, 2 and 3 years
The number of participants with hospitalisation for Heart failure
The number and dates of hospitalisations for heart failure (such as acute heart failure or decompensated chronic heart failure) will be recorded from medical record review.
Measured: 1, 2 and 3 years
The number of participants with Fractures
The number and dates of fractures (classified by anatomical site, such as hip, vertebral, or upper limb) will be recorded from medical record review.
Measured: 1, 2 and 3 years
The number of participants with Bleeding events
The number and dates of bleeding events (classified as major or minor according to ISTH definition) will be recorded from medical record review.
Measured: 1, 2 and 3 years
The number of participants with Interventions for vascular diseases
The number and dates of surgical and endovascular interventions (such as revascularization, bypass or amputation) for atherosclerotic cardiovascular diseases (such as coronary and peripheral artery disease) will be recorded from medical record review.
Measured: 1, 2 and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start15 Oct 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 475 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Elisabethinen Hospital, Landeskrankenhaus Feldkirch
- Responsible party
- Sponsor
- Investigators
- Kathrin Eller, Univ.-Prof., Principal investigator, Division of Nephrology, Department of Internal Medicine, Medical University of Graz, Graz, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170761
- Sponsor's protocol ID
- 34-322 ex 21/22
- Acronym
- HEMOcalc
- Status last verified
- Aug 2025
- First submitted
- 27 Aug 2025
- Last updated
- 5 Mar 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 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional Biomarker Study for Vascular Calcification in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT07170761
- Acronym / sponsor ID
- HEMOcalc / 34-322 ex 21/22
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 475 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Elisabethinen Hospital, Landeskrankenhaus Feldkirch
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Sep 2025 (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.
Parathyroid hormone (PTH) remains the central biomarker to classify CKD-metabolic bone disease (CKD-MBD) in hemodialysis patients. While PTH-values are known to be associated with adverse outcomes, interventional studies have failed to show a benefit of pharmacological modulation of PTH levels on hard clinical outcomes. To address this gap, the investigators explored alternative markers of bone metabolism, vascular calcification and inflammation in association to prospective event patterns.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prevalent, chronic hemodialysis patients
Key inclusion criteria (1 listed)
- Stable hemodialysis > 3 months duration
Key exclusion criteria (2 listed)
- Pregnancy
- Acute infections or antibiotic treatment (within 4 weeks)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: 1, 2 and 3 years
All-causes, the date of death will be recorded.
7 secondary outcomes
Cause-specific mortality
Time frame: 1, 2 and 3 years
MACE
Time frame: 1, 2 and 3 years
The number of participants with hospitalisation for Infection
Time frame: 1, 2 and 3 years
The number of participants with hospitalisation for Heart failure
Time frame: 1, 2 and 3 years
The number of participants with Fractures
Time frame: 1, 2 and 3 years
The number of participants with Bleeding events
Time frame: 1, 2 and 3 years
The number of participants with Interventions for vascular diseases
Time frame: 1, 2 and 3 years
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 5 Mar 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. This study is not recruiting at the moment.
Kathrin Eller, Univ.-Prof. principal investigator
Division of Nephrology, Department of Internal Medicine, Medical University of Graz, Graz, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Disease and CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder, run by Medical University of Graz at 1 site in Austria.
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 1 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Mortality (time frame: 1, 2 and 3 years). 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 5 Mar 2026.