Pilot Medical Evaluation of the T50 Test

Not Applicable

Completed

• Conditions: Renal Failure; Cardiovascular Diseases; Vascular Calcification
• Interventions: Diagnostic Test: T50 Calcification Inhibition Test (CIT)

• Registration Number: NCT03292029
• Lead Sponsor: Fresenius Medical Care Deutschland GmbH

Brief 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.

Study Timeline

• Study First Submitted: 2017-09-20
• Study First Submitted QC: 2017-09-20
• Study Start: 2017-09-22
• Study First Posted: 2017-09-25
• Primary Completion: 2019-10-05
• Study Completion: 2020-03-04
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-08
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 776

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
T50 Calcification Inhibition Test (CIT)	T50 Calcification Inhibition Test (CIT)	Measurement of T50 CIT and fetuin-A serum values

Primary Outcome Measures

Name	Time	Method
T50 CIT values	Baseline after signed informed consent	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.

Trial Locations

Locations (8)

Centro de Diálisis Barcelona - Diagonal; 🇪🇸 Barcelona, Spain

Centro de Diálisis Terrassa; 🇪🇸 Terrassa, Spain

Centro de Diálisis Barcelona - Glories; 🇪🇸 Barcelona, Spain

Centro de Diálisis Reus; 🇪🇸 Reus, Spain

Centro de Diálisis Granollers; 🇪🇸 Granollers, Spain

Centro de Diálisis Hospitalet; 🇪🇸 L'Hospitalet De Llobregat, Spain

Centro de Diálisis Barcelona - Rosselló; 🇪🇸 Barcelona, Spain

Centro de Diálisis Tarragona; 🇪🇸 Tarragona, Spain