Pilot Medical Evaluation of the T50 Test

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.

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