Renal FailureNCT03292029
Pilot Medical Evaluation of the T50 Test
A study testing T50 Calcification Inhibition Test (CIT) in people with Renal Failure and Cardiovascular Diseases, run by Fresenius Medical Care Deutschland GmbH at 8 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure, Cardiovascular Diseases, Vascular Calcification
- What is being tested?
- T50 Calcification Inhibition Test (CIT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 776 participants
- Where
- 8 sitesSpain
- Study dates
- 22 Sep 2017to 4 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Spain8 sites
Centro de Diálisis Barcelona - Glories
Barcelona, 08013
Centro de Diálisis Barcelona - Diagonal
Barcelona, 08019
Centro de Diálisis Barcelona - Rosselló
Barcelona, 08029
Centro de Diálisis Granollers
Granollers, 08401
Centro de Diálisis Hospitalet
L'Hospitalet de Llobregat, 08901
Centro de Diálisis Reus
Reus, 43205
Centro de Diálisis Tarragona
Tarragona, 43007
Centro de Diálisis Terrassa
Terrassa, 08223
About this study
Official title: 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.
Read the 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.
- Being tested
- T50 Calcification Inhibition Test (CIT)
- Keywords
- Renal replacement therapy, Haemodialsysis, Calcification Inhibition Test
- Medical subject headings
- Renal Insufficiency, Cardiovascular Diseases, Vascular Calcification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T50 Calcification Inhibition Test (CIT)Diagnostic test
Measurement of predialysis T50 CIT and fetuin-A values in serum of hemodialysis patients
| Study group | Role | What they receive |
|---|---|---|
| T50 Calcification Inhibition Test (CIT) | Other | Measurement of T50 CIT and fetuin-A serum values Receives: Diagnostic Test: T50 Calcification Inhibition Test (CIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline after signed informed consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start22 Sep 2017
- Primary completion5 Oct 2019
- Study completion4 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Exploratory, interventional, open, multi-center, prospective
- Masking
- None (open label)
- Enrolment
- 776 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care Deutschland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abraham Rincon Bello, Dr., Principal investigator, Fresenius Medical Care Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03292029
- Sponsor's protocol ID
- HD-T50-01-ES
- Status last verified
- Feb 2022
- First submitted
- 20 Sep 2017
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36792998
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Medical Evaluation of the T50 Calcification Inhibition Test in NephroCare Clinics
- ClinicalTrials.gov ID
- NCT03292029
- Acronym / sponsor ID
- HD-T50-01-ES
- Keywords
- Renal replacement therapy, Haemodialsysis, Calcification Inhibition Test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 776 participants (actual)
- Lead sponsor
- Fresenius Medical Care Deutschland GmbHIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2017 (actual)
- Primary completion
- 5 Oct 2019 (actual)
- Study completion
- 4 Mar 2020 (actual)
- First posted
- 25 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Exploratory, interventional, open, multi-center, prospective
| Arm | Type | Receives |
|---|---|---|
| T50 Calcification Inhibition Test (CIT) | Other | Diagnostic Test: T50 Calcification Inhibition Test (CIT)Measurement of T50 CIT and fetuin-A serum values |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T50 Calcification Inhibition Test (CIT)Measurement of predialysis T50 CIT and fetuin-A values in serum of hemodialysis patients | Diagnostic test | T50 Calcification Inhibition Test (CIT) |
Primary outcome
T50 CIT values
Time frame: Baseline after signed informed consent
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Derived from this study: PubMed 36792998Zawada 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abraham Rincon Bello, Dr. principal investigator
Fresenius Medical Care Spain
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T50 Calcification Inhibition Test (CIT) in people with Renal Failure and Cardiovascular Diseases, run by Fresenius Medical Care Deutschland GmbH at 8 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T50 CIT values (time frame: Baseline after signed informed consent). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03292029, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.