Pilot Medical Evaluation of the T50 Test

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03292029
• Other study ID #: HD-T50-01-ES
• Status: Completed
• Phase: N/A
• Start date: September 22, 2017
• Est. completion date: March 4, 2020

Study information

• Verified date: February 2022
• Source: Fresenius Medical Care Deutschland GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 776
• Est. completion date: March 4, 2020
• Est. primary completion date: October 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Calcinosis
• Cardiovascular Diseases
• Renal Failure
• Vascular Calcification

Intervention

Diagnostic Test:
• T50 Calcification Inhibition Test (CIT)
Measurement of predialysis T50 CIT and fetuin-A values in serum of hemodialysis patients

Locations

Country	Name	City	State
Spain	Centro de Diálisis Barcelona - Diagonal	Barcelona
Spain	Centro de Diálisis Barcelona - Glories	Barcelona
Spain	Centro de Diálisis Barcelona - Rosselló	Barcelona
Spain	Centro de Diálisis Granollers	Granollers
Spain	Centro de Diálisis Hospitalet	L'Hospitalet De Llobregat
Spain	Centro de Diálisis Reus	Reus
Spain	Centro de Diálisis Tarragona	Tarragona
Spain	Centro de Diálisis Terrassa	Terrassa

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Medical Care Deutschland GmbH

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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