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
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.
- 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