NCT03292029

Pilot Medical Evaluation of the T50 Test

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 776 (actual)
• Sponsor: Fresenius Medical Care Deutschland GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Renal Failure
• Cardiovascular Diseases
• Vascular Calcification

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	T50 Calcification Inhibition Test (CIT)	Measurement of predialysis T50 CIT and fetuin-A values in serum of hemodialysis patients

Timeline

• Start date: 2017-09-22
• Primary completion: 2019-10-05
• Completion: 2020-03-04
• First posted: 2017-09-25
• Last updated: 2022-02-09

Locations

8 sites across 1 country: Spain