Pilot Medical Evaluation of the T50 Test

Fresenius Medical Care (FMC)

Status: Completed

Conditions: Renal Failure; Vascular Calcification; Cardiovascular Diseases

Treatments: Diagnostic Test: T50 Calcification Inhibition Test (CIT)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03292029

HD-T50-01-ES

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 776 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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776 participants in 1 patient group

T50 Calcification Inhibition Test (CIT)

Other group

Description:

Measurement of T50 CIT and fetuin-A serum values

Treatment:

Diagnostic Test: T50 Calcification Inhibition Test (CIT)