Biomarkers and Event Patterns of Vascular Disease in Hemodialysis

NCT07170761 | Active Not Recruiting

• 1 other identifier: 34-322 ex 21/22
• Study Type: observational
• Target: 475
• Locations: 1 country
• Sites: 1

Brief 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 outcomes. To address this gap, the investigators explored alternative markers of bone metabolism, vascular calcification and inflammation in association to prospective event patterns.

Conditions

Vascular Disease; CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder

Outcome Measures

Primary Outcomes (1)

• Mortality

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

  1, 2 and 3 years

Secondary Outcomes (7)

• Cause-specific mortality

  1, 2 and 3 years

• MACE

  1, 2 and 3 years

• The number of participants with hospitalisation for Infection

  1, 2 and 3 years

• The number of participants with hospitalisation for Heart failure

  1, 2 and 3 years

• The number of participants with Fractures

  1, 2 and 3 years

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Prevalent, chronic hemodialysis patients

You may qualify if:

• Stable hemodialysis \> 3 months duration

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Graz: lead
• Elisabethinen Hospital: collaborator
• Landeskrankenhaus Feldkirch: collaborator

Study Sites (1)

Medical University Graz

Graz, Styria, 8036, Austria

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Vascular Diseases; Chronic Kidney Disease-Mineral and Bone Disorder

Condition Hierarchy (Ancestors)

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

Study Officials

• Kathrin Eller, Univ.-Prof.

  Division of Nephrology, Department of Internal Medicine, Medical University of Graz, Graz, Austria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 12, 2025
• Study Start: October 15, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 5, 2026

Record last verified: 2025-08

Locations

AU (1)