Pilot Medical Evaluation of the T50 Test

Study Overview
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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.

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.

Official Title
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Pilot Medical Evaluation of the T50 Calcification Inhibition Test in NephroCare Clinics

Conditions
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Renal Failure, Cardiovascular Diseases, Vascular Calcification

Intervention / Treatment
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* Diagnostic Test: T50 Calcification Inhibition Test (CIT)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Exploratory, interventional, open, multi-center, prospective
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: T50 Calcification Inhibition Test (CIT)<br>Measurement of T50 CIT and fetuin-A serum values | Diagnostic Test: T50 Calcification Inhibition Test (CIT)<br>* Measurement of predialysis T50 CIT and fetuin-A values in serum of hemodialysis patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T50 CIT values | The primary objective of this pilot study is to exploratory examine the predictive power of baseline T50 CIT values in terms of their association with time to all-cause mortality in haemodialysis patients. | Baseline after signed informed consent | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal replacement therapy, Haemodialsysis, Calcification Inhibition Test