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NCT Number: NCT07170761

Biomarkers and Event Patterns of Vascular Disease in Hemodialysis

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Vascular Disease Avitaminosis Bone Diseases Bone Diseases, Metabolic CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder Calcium Metabolism Disorders Cardiovascular Diseases Chronic Disease Chronic Kidney Disease-Mineral and Bone Disorder Deficiency Diseases Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperparathyroidism Hyperparathyroidism, Secondary Kidney Diseases Male Urogenital Diseases Malnutrition Metabolic Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Parathyroid Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rickets Urogenital Diseases Urologic Diseases Vascular Diseases Vitamin D Deficiency

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University Graz

Graz, Styria, 8036, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stable hemodialysis > 3 months duration

Exclusion criteria

  • Pregnancy
  • Acute infections or antibiotic treatment (within 4 weeks)

Treatment and study plan

Primary outcomes

  1. Mortality

    Time frame: 1, 2 and 3 years

    All-causes, the date of death will be recorded.

Secondary outcomes

  1. Cause-specific mortality

    Time frame: 1, 2 and 3 years

    The cause of death will be recorded.

  2. MACE

    Time frame: 1, 2 and 3 years

    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.

  3. The number of participants with hospitalisation for Infection

    Time frame: 1, 2 and 3 years

    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.

  4. The number of participants with hospitalisation for Heart failure

    Time frame: 1, 2 and 3 years

    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.

  5. The number of participants with Fractures

    Time frame: 1, 2 and 3 years

    The number and dates of fractures (classified by anatomical site, such as hip, vertebral, or upper limb) will be recorded from medical record review.

  6. The number of participants with Bleeding events

    Time frame: 1, 2 and 3 years

    The number and dates of bleeding events (classified as major or minor according to ISTH definition) will be recorded from medical record review.

  7. The number of participants with Interventions for vascular diseases

    Time frame: 1, 2 and 3 years

    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.

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Collaborators

  • Elisabethinen Hospital
  • Landeskrankenhaus Feldkirch

Registry information

Official study title

Cross-sectional Biomarker Study for Vascular Calcification in Hemodialysis Patients

Acronym: HEMOcalc

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Sep 12, 2025
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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