An interventional study of T50 Calcification Inhibition Test (CIT) in Renal Failure, Cardiovascular Diseases and Vascular Calcification, sponsored by Fresenius Medical Care Deutschland GmbH. Completed at 8 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-09.
Sponsored by Fresenius Medical Care Deutschland GmbH (part of Fresenius Medical Care) · Not applicable, Interventional, and Other
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.
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.
1,409 studies on the registry are indexed under Renal Insufficiency; 143 are open to participants now.
This study's enrollment of 776 is above the median of 40 across 1,058 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →Fresenius Medical Care Deutschland GmbH is the lead sponsor of 36 studies on the registry; 7 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Time frame: Baseline after signed informed consent
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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