Biomarkers and Event Patterns of Vascular Disease in Hemodialysis

NCT ID: NCT07170761

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 475 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-15
• Study Completion Date: 2027-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Stable hemodialysis > 3 months duration

Exclusion Criteria

• Pregnancy
• Acute infections with antibiotic treatment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LKH Feldkirch

UNKNOWN

Sponsor Role: collaborator

Elisabethinen Hospital

OTHER

Sponsor Role: collaborator

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathrin Eller, Univ.-Prof.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Medical University Graz

Graz, Styria, Austria

Countries

Austria

Other Identifiers

34-322 ex 21/22

Identifier Type: -

Identifier Source: org_study_id