Pilot Medical Evaluation of the T50 Test

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

776 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-22

Study Completion Date

2020-03-04

Brief Summary

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This pilot study aims to evaluate in an exploratory way the predictive power of a novel in vitro test (T50 Calcification Inhibition Test, T50 CIT), which measures the mineralization inhibition capacity of blood, in terms of its association with time to all-cause mortality in haemodialysis patients.

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Detailed Description

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Disturbances in mineral and bone metabolism centrally contribute to the exceedingly elevated risk for cardiovascular (CV) disease in dialysis patients. A novel in vitro test (T50 Calcification Inhibition Test, T50 CIT) has been developed, which measures the mineralization inhibition capacity of blood. This pilot study aims to exploratory examine the predictive power of baseline T50 CIT and fetuin-A (protein which is centrally involved in the inhibition of the formation of crystalline hydroxyapatite) values in terms of their association with all-cause mortality in an unselected cohort of haemodialysis patients. Moreover, the study shall investigate the association between baseline T50 CIT and fetuin-A values with CV related mortality, all-cause hospitalization and CV related hospitalization. Finally, the study aims to compare the predictive power of T50 CIT values with a set of six established calcification-related parameters (albumin, phosphate, calcium, magnesium, bicarbonate and fetuin-A). After baseline blood sampling the patients will be followed for 2 years.

Conditions

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Renal Failure Cardiovascular Diseases Vascular Calcification

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Exploratory, interventional, open, multi-center, prospective

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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T50 Calcification Inhibition Test (CIT)

Measurement of T50 CIT and fetuin-A serum values

Group Type OTHER

T50 Calcification Inhibition Test (CIT)

Intervention Type DIAGNOSTIC_TEST

Measurement of predialysis T50 CIT and fetuin-A values in serum of hemodialysis patients

Interventions

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T50 Calcification Inhibition Test (CIT)

Measurement of predialysis T50 CIT and fetuin-A values in serum of hemodialysis patients

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Informed consent signed and dated by study patient and investigator/authorised physician
* Minimum age of 18 years
* Incident and prevalent haemodialysis patients
* Three haemodialysis treatments per week

Exclusion Criteria

* Any condition which could interfere with the patient's ability to comply with the study
* Pregnancy (pregnancy test will be conducted with female patients aged \<= 55 years) or lactation period
* Participation in an interventional clinical study during the preceding 30 days

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No