Pilot Medical Evaluation of the T50 Test
1 other identifier
interventional
776
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2017
Typical duration for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2017
CompletedStudy Start
First participant enrolled
September 22, 2017
CompletedFirst Posted
Study publicly available on registry
September 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 4, 2020
CompletedFebruary 9, 2022
February 1, 2022
2 years
September 20, 2017
February 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
T50 Calcification Inhibition Test (CIT)
OTHERMeasurement of T50 CIT and fetuin-A serum values
Interventions
Measurement of predialysis T50 CIT and fetuin-A values in serum of hemodialysis patients
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Centro de Diálisis Barcelona - Glories
Barcelona, 08013, Spain
Centro de Diálisis Barcelona - Diagonal
Barcelona, 08019, Spain
Centro de Diálisis Barcelona - Rosselló
Barcelona, 08029, Spain
Centro de Diálisis Granollers
Granollers, 08401, Spain
Centro de Diálisis Hospitalet
L'Hospitalet de Llobregat, 08901, Spain
Centro de Diálisis Reus
Reus, 43205, Spain
Centro de Diálisis Tarragona
Tarragona, 43007, Spain
Centro de Diálisis Terrassa
Terrassa, 08223, Spain
Related Publications (1)
Zawada AM, Wolf M, Rincon Bello A, Ramos-Sanchez R, Hurtado Munoz S, Ribera Tello L, Mora-Macia J, Fernandez-Robres MA, Soler-Garcia J, Aguilera Jover J, Moreso F, Stuard S, Stauss-Grabo M, Winter A, Canaud B. Assessment of a serum calcification propensity test for the prediction of all-cause mortality among hemodialysis patients. BMC Nephrol. 2023 Feb 15;24(1):35. doi: 10.1186/s12882-023-03069-6.
PMID: 36792998DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Abraham Rincon Bello, Dr.
Fresenius Medical Care Spain
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2017
First Posted
September 25, 2017
Study Start
September 22, 2017
Primary Completion
October 5, 2019
Study Completion
March 4, 2020
Last Updated
February 9, 2022
Record last verified: 2022-02