Pilot Medical Evaluation of the T50 Test

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Renal Failure; Vascular Calcification
• Intervention / Treatment: Diagnostic test: T50 Calcification Inhibition Test (CIT)

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 Type: Interventional
• Enrollment (Actual): 776
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08013
    • Centro de Diálisis Barcelona - Glories
  • Barcelona, Spain, 08019
    • Centro de Diálisis Barcelona - Diagonal
  • Barcelona, Spain, 08029
    • Centro de Diálisis Barcelona - Rosselló
  • Granollers, Spain, 08401
    • Centro de Diálisis Granollers
  • L'Hospitalet De Llobregat, Spain, 08901
    • Centro de Diálisis Hospitalet
  • Reus, Spain, 43205
    • Centro de Diálisis Reus
  • Tarragona, Spain, 43007
    • Centro de Diálisis Tarragona
  • Terrassa, Spain, 08223
    • Centro de Diálisis Terrassa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: T50 Calcification Inhibition Test (CIT); Measurement of T50 CIT and fetuin-A serum values	Diagnostic test: T50 Calcification Inhibition Test (CIT); Measurement of predialysis T50 CIT and fetuin-A values in serum of hemodialysis patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fresenius Medical Care Deutschland GmbH
• Investigators: Principal Investigator: Abraham Rincon Bello, Dr., Fresenius Medical Care Spain

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2017
• Primary Completion (Actual): October 5, 2019
• Study Completion (Actual): March 4, 2020

Study Registration Dates

• First Submitted: September 20, 2017
• First Submitted That Met QC Criteria: September 20, 2017
• First Posted (Actual): September 25, 2017

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Renal replacement therapy; Haemodialsysis; Calcification Inhibition Test
• Additional Relevant MeSH Terms: Metabolic Diseases; Calcium Metabolism Disorders; Cardiovascular Diseases; Calcinosis; Vascular Calcification
• Other Study ID Numbers: HD-T50-01-ES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No