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Pilot Medical Evaluation of the T50 Test

Primary Purpose

Renal Failure, Cardiovascular Diseases, Vascular Calcification

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
T50 Calcification Inhibition Test (CIT)
Sponsored by
Fresenius Medical Care Deutschland GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Renal Failure focused on measuring Renal replacement therapy, Haemodialsysis, Calcification Inhibition Test

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centro de Diálisis Barcelona - Glories
  • Centro de Diálisis Barcelona - Diagonal
  • Centro de Diálisis Barcelona - Rosselló
  • Centro de Diálisis Granollers
  • Centro de Diálisis Hospitalet
  • Centro de Diálisis Reus
  • Centro de Diálisis Tarragona
  • Centro de Diálisis Terrassa

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

T50 Calcification Inhibition Test (CIT)

Arm Description

Measurement of T50 CIT and fetuin-A serum values

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 20, 2017
Last Updated
February 8, 2022
Sponsor
Fresenius Medical Care Deutschland GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT03292029
Brief Title
Pilot Medical Evaluation of the T50 Test
Official Title
Pilot Medical Evaluation of the T50 Calcification Inhibition Test in NephroCare Clinics
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 22, 2017 (Actual)
Primary Completion Date
October 5, 2019 (Actual)
Study Completion Date
March 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fresenius Medical Care Deutschland GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure, Cardiovascular Diseases, Vascular Calcification
Keywords
Renal replacement therapy, Haemodialsysis, Calcification Inhibition Test

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Exploratory, interventional, open, multi-center, prospective
Masking
None (Open Label)
Allocation
N/A
Enrollment
776 (Actual)

8. Arms, Groups, and Interventions

Arm Title
T50 Calcification Inhibition Test (CIT)
Arm Type
Other
Arm Description
Measurement of T50 CIT and fetuin-A serum values
Intervention Type
Diagnostic Test
Intervention Name(s)
T50 Calcification Inhibition Test (CIT)
Intervention Description
Measurement of predialysis T50 CIT and fetuin-A values in serum of hemodialysis patients
Primary Outcome Measure Information:
Title
T50 CIT values
Description
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.
Time Frame
Baseline after signed informed consent

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abraham Rincon Bello, Dr.
Organizational Affiliation
Fresenius Medical Care Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Diálisis Barcelona - Glories
City
Barcelona
ZIP/Postal Code
08013
Country
Spain
Facility Name
Centro de Diálisis Barcelona - Diagonal
City
Barcelona
ZIP/Postal Code
08019
Country
Spain
Facility Name
Centro de Diálisis Barcelona - Rosselló
City
Barcelona
ZIP/Postal Code
08029
Country
Spain
Facility Name
Centro de Diálisis Granollers
City
Granollers
ZIP/Postal Code
08401
Country
Spain
Facility Name
Centro de Diálisis Hospitalet
City
L'Hospitalet De Llobregat
ZIP/Postal Code
08901
Country
Spain
Facility Name
Centro de Diálisis Reus
City
Reus
ZIP/Postal Code
43205
Country
Spain
Facility Name
Centro de Diálisis Tarragona
City
Tarragona
ZIP/Postal Code
43007
Country
Spain
Facility Name
Centro de Diálisis Terrassa
City
Terrassa
ZIP/Postal Code
08223
Country
Spain

12. IPD Sharing Statement

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Pilot Medical Evaluation of the T50 Test

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