Biomarkers and Event Patterns of Vascular Disease in Hemo... | NCT07170761

Studies
Biomarkers and Event Patterns of Vascular Disease in Hemodialysis

NCT07170761

Sponsor

Medical University of Graz

Status

Active, not recruiting

Last Update Posted

Mar 5, 2026Actual

Enrollment

475Actual

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2022Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Aug 27, 2025

First Submission Date that Met QC Criteria

Sep 11, 2025

First Posted Date

Sep 12, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2026

Last Update Posted Date

Mar 5, 2026Actual

Name	Class
Elisabethinen Hospital	OTHER
Landeskrankenhaus Feldkirch	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

475Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	All-causes, the date of death will be recorded.	1, 2 and 3 years

Secondary Outcomes

Measure	Description	Time Frame
Cause-specific mortality	The cause of death will be recorded.	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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Stable hemodialysis > 3 months duration

Exclusion Criteria:

Pregnancy
Acute infections or antibiotic treatment (within 4 weeks)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Prevalent, chronic hemodialysis patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kathrin Eller, Univ.-Prof.	Division of Nephrology, Department of Internal Medicine, Medical University of Graz, Graz, Austria	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University Graz		Graz	Styria	8036	Austria

Condition Browse Module

MeSH Terms

ID	Term
D014652	Vascular Diseases
D012080	Chronic Kidney Disease-Mineral and Bone Disorder

Ancestor Terms

ID	Term
D002318	Cardiovascular Diseases
D012279	Rickets
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases

Browse Leaves

Not provided

Browse Branches

Not provided