Clinical trial NCT03292029: Pilot Medical Evaluation of the T50 Test
Official title: Pilot Medical Evaluation of the T50 Calcification Inhibition Test in NephroCare Clinics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Failure
Cardiovascular Diseases
Vascular Calcification
Keywords: Renal replacement therapy
Haemodialsysis
Calcification Inhibition Test
Lead sponsor: Fresenius Medical Care Deutschland GmbH
Sponsor class: INDUSTRY
First posted: 2017-09-25
Enrollment: 776
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Exploratory, interventional, open, multi-center, prospective
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: T50 CIT values
timeFrame: Baseline after signed informed consent
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Centro de Diálisis Barcelona - Glories
city: Barcelona
country: Spain
facility: Centro de Diálisis Barcelona - Diagonal
city: Barcelona
country: Spain
facility: Centro de Diálisis Barcelona - Rosselló
city: Granollers
country: Spain
facility: Centro de Diálisis Granollers
city: L'Hospitalet De Llobregat
country: Spain
facility: Centro de Diálisis Hospitalet
city: Reus
country: Spain
facility: Centro de Diálisis Reus
city: Tarragona
country: Spain
facility: Centro de Diálisis Tarragona
city: Terrassa
country: Spain
facility: Centro de Diálisis Terrassa
Study officials:
affiliation: Fresenius Medical Care Spain
name: Abraham Rincon Bello, Dr.
role: PRINCIPAL_INVESTIGATOR
References: