Chronic Kidney Disease Requiring Chronic DialysisNCT03942744
The Effect of High-flux Hemodialysis and On-line Hemodiafiltration on Endothelial Function.
A study testing on-line hemodiafiltration in people with Chronic Kidney Disease Requiring Chronic Dialysis, run by Maimónides Biomedical Research Institute of Córdoba at 2 sites in Spain.
Trial summary
The main aim of this project is to evaluate, in patients with chronic kidney disease (CKD5D), the role of adhesion molecules in leukocyte adhesion and transendothelial migration involved in atherogenesis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease Requiring Chronic Dialysis
- What is being tested?
- on-line hemodiafiltration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 2 sitesSpain
- Study dates
- 8 Nov 2018to 25 Feb 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Vascular access with a blood flow > 300ml/min
- Age >18 <80 years written informed consent
Who cannot join
- Neoplasia
- B hepatitis
- Acute or chronic inflammation life expectance less than one year Included in living donor transplant list immunosupressive drugs
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital universitario Reina Sofia
Córdoba, Cordoba, 14004
Alejandro Martinmalo
Córdoba, Córdoba, 14004
About this study
Official title: Molecular Mechanisms Involved in Cell Adhesion and Migration Process: Effect of Treatment of Chronic Kidney Disease on Endothelial Dysfunction
The main aim of this project is to evaluate, in patients with chronic kidney disease (CKD5D), the role of adhesion molecules in leukocyte adhesion and transendothelial migration involved in atherogenesis. This trial is a prospective randomized crossover study in CKD5D hemodialysis patients followed in the Nephrology Unit of the Reina Sofia University Hospital (Cordoba, Spain). The estimated inclusion period is two years, with a follow-up of 24 months. Patients will be randomized to high-flux hemodialysis versus online hemodiafiltration with high convective transport (above 21 liters); after 6 months in each dialysis modality they will be switched the other technique for another 6 months. Then, patients will be maintained during 4 weeks in conventional hemodialysis "wash out period", before being started in the other dialysis modality.
Read the detailed description
The main aim of this project is to evaluate, in patients with chronic kidney disease (CKD5D), the role of adhesion molecules in leukocyte adhesion and transendothelial migration involved in atherogenesis. This trial is a prospective randomized crossover study in CKD5D hemodialysis patients followed in the Nephrology Unit of the Reina Sofia University Hospital (Cordoba, Spain). The estimated inclusion period is two years, with a follow-up of 24 months. Patients will be randomized to high-flux hemodialysis versus online hemodiafiltration with high convective transport (above 21 liters); after 6 months in each dialysis modality they will be switched the other technique for another 6 months. Then, patients will be maintained during 4 weeks in conventional hemodialysis "wash out period", before being started in the other dialysis modality. Patients will be stratified by age, gender and the presence of diabetes. Routine analytical determinations (urea, creatinine, sodium, potassium, chlorine, total CO2, calcium, phosphorus, FA, PTH, levels 25OH, β2m, ALT, hemoglobin, leukocytes, platelets, glucose, uric acid, total proteins, albumin , PCR, IL-6, ferritin, TSAT and homocysteine), characteristics of hemodialysis and dialysis dose (Kt / V and Kt) will be recorded. Residual renal function will be analysed every three months. In plasma, microRNAs profile and FGF23 levels will be determined. Markers of endothelial dysfunction (CD31 +, CD41-, CD144, CD62E) and subclinical atherosclerosis markers (CD11b, CD41 +) will be measured. The hospitalization and mortality rate due to cardiovascular causes and concurrent cardiovascular events throughout the study (acute myocardial infarction, stroke, transient ischemic attack and peripheral vascular disease) will be assessed along the study period.
- Being tested
- on-line hemodiafiltration
- Keywords
- Hemodialysis, Endothelial dysfunction, Atherogenesis
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
on-line hemodiafiltrationDevice
on-line postdilutional hemodiafiltration with high convective transport above 21 liters
| Study group | Role | What they receive |
|---|---|---|
| high-flux hemodialysis | No intervention | high-flux hemodialysis cut-off membrane above 50 |
| on-line hemodiafiltration | Active comparator | postdilutional on-line hemodiafiltration with a convective transport above 21 liters Receives: Device: on-line hemodiafiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of two different dialysis modalities (high flux vs online hemodiafiltration) on endothelial function markers: CD31,CD41,CD34; as measured by the percent of labeled cells obtained by flow cytometry.
These parameters will assessed, in patients with chronic kidney disease (CKD5D), Blood will be drawn before the dialysis session following the scheduled of the protocol. The measuremets of CD31 CD41 CD34 will be performend by flow cytometry according to the standard methodology described in methods.
Measured: 6 months
Secondary outcomes (3)
Effect of two different dialysis modalities ( high flux vs online hemodiafiltration) on hospitalization (hospital admission days/year).
Effect of two different dialysis modalities ( high flux vs online hemodiafiltration) on hospitalization (hospital admission days/year). Cardiovascular causes and concurrent cardiovascular events throughout the study (acute myocardial infarction, stroke, transient ischemic attack and peripheral vascular disease) will be also recorded throughout the study.
Measured: 6 months
Effect of two different dialysis modalities ( high flux vs online hemodiafiltration) on Serum concentration of Fibroblast Growth Factor FGF23 (pg/ml) .
The serum concentration of Fibroblast Growth Factor FGF23 will be quantified using commercially available ELISA Kit. (pg/ml). Blood samples will be obtained before the dialysis session.
Measured: 6 months
Effect of two different dialysis modalities ( high flux vs online hemodiafiltration) on vascular injury related microRNAs (relative expression)
The relative expression of microRNAs (126-3p, 223-3p,363-3p, 191-5p). will be determined by RTq-PCR. Blood samples will be obtained before the dialysis session.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start8 Nov 2018
- Primary completion30 Nov 2021
- Study completion25 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease Requiring Chronic DialysisStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- prospective randomized crossover study
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Principal investigator, Alejandro Martin-Malo, Maimónides Biomedical Research Institute of Córdoba
- Investigators
- alejandro martin-malo, MD, Principal investigator, Maimónides Biomedical Research Institute of Córdoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03942744
- Sponsor's protocol ID
- PI17/01785
- Status last verified
- Mar 2022
- First submitted
- 5 Mar 2019
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual data will be available in this report after deidenttification (text, tables, figures and appendices) to those researchers who provide a methodologically sound proposal and for meta-analysis.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Mechanisms Involved in Cell Adhesion and Migration Process: Effect of Treatment of Chronic Kidney Disease on Endothelial Dysfunction
- ClinicalTrials.gov ID
- NCT03942744
- Acronym / sponsor ID
- PI17/01785
- Keywords
- Hemodialysis, Endothelial dysfunction, Atherogenesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 25 Feb 2022 (actual)
- First posted
- 8 May 2019 (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.
The main aim of this project is to evaluate, in patients with chronic kidney disease (CKD5D), the role of adhesion molecules in leukocyte adhesion and transendothelial migration involved in atherogenesis. This trial is a prospective randomized crossover study in CKD5D hemodialysis patients followed in the Nephrology Unit of the Reina Sofia University Hospital (Cordoba, Spain). The estimated inclusion period is two years, with a follow-up of 24 months. Patients will be randomized to high-flux hemodialysis versus online hemodiafiltration with high convective transport (above 21 liters); after 6 months in each dialysis modality they will be switched the other technique for another 6 months. Then, patients will be maintained during 4 weeks in conventional hemodialysis "wash out period", before being started in the other dialysis modality.
Detailed description
The main aim of this project is to evaluate, in patients with chronic kidney disease (CKD5D), the role of adhesion molecules in leukocyte adhesion and transendothelial migration involved in atherogenesis. This trial is a prospective randomized crossover study in CKD5D hemodialysis patients followed in the Nephrology Unit of the Reina Sofia University Hospital (Cordoba, Spain). The estimated inclusion period is two years, with a follow-up of 24 months. Patients will be randomized to high-flux hemodialysis versus online hemodiafiltration with high convective transport (above 21 liters); after 6 months in each dialysis modality they will be switched the other technique for another 6 months. Then, patients will be maintained during 4 weeks in conventional hemodialysis "wash out period", before being started in the other dialysis modality. Patients will be stratified by age, gender and the presence of diabetes. Routine analytical determinations (urea, creatinine, sodium, potassium, chlorine, total CO2, calcium, phosphorus, FA, PTH, levels 25OH, β2m, ALT, hemoglobin, leukocytes, platelets, glucose, uric acid, total proteins, albumin , PCR, IL-6, ferritin, TSAT and homocysteine), characteristics of hemodialysis and dialysis dose (Kt / V and Kt) will be recorded. Residual renal function will be analysed every three months. In plasma, microRNAs profile and FGF23 levels will be determined. Markers of endothelial dysfunction (CD31 +, CD41-, CD144, CD62E) and subclinical atherosclerosis markers (CD11b, CD41 +) will be measured. The hospitalization and mortality rate due to cardiovascular causes and concurrent cardiovascular events throughout the study (acute myocardial infarction, stroke, transient ischemic attack and peripheral vascular disease) will be assessed along the study period.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective randomized crossover study
| Arm | Type | Receives |
|---|---|---|
| high-flux hemodialysis | No intervention | –high-flux hemodialysis cut-off membrane above 50 |
| on-line hemodiafiltration | Active comparator | Device: on-line hemodiafiltrationpostdilutional on-line hemodiafiltration with a convective transport above 21 liters |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Vascular access with a blood flow > 300ml/min
- Age >18 <80 years written informed consent
Key exclusion criteria (3 listed)
- Neoplasia
- B hepatitis
- Acute or chronic inflammation life expectance less than one year Included in living donor transplant list immunosupressive drugs
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 |
|---|---|---|
| on-line hemodiafiltrationon-line postdilutional hemodiafiltration with high convective transport above 21 liters | Device | on-line hemodiafiltration |
Primary outcome
Effect of two different dialysis modalities (high flux vs online hemodiafiltration) on endothelial function markers: CD31,CD41,CD34; as measured by the percent of labeled cells obtained by flow cytometry.
Time frame: 6 months
These parameters will assessed, in patients with chronic kidney disease (CKD5D), Blood will be drawn before the dialysis session following the scheduled of the protocol. The measuremets of CD31 CD41 CD34 will be performend by flow cytometry according to the standard methodology described in methods.
3 secondary outcomes
Effect of two different dialysis modalities ( high flux vs online hemodiafiltration) on hospitalization (hospital admission days/year).
Time frame: 6 months
Effect of two different dialysis modalities ( high flux vs online hemodiafiltration) on Serum concentration of Fibroblast Growth Factor FGF23 (pg/ml) .
Time frame: 6 months
Effect of two different dialysis modalities ( high flux vs online hemodiafiltration) on vascular injury related microRNAs (relative expression)
Time frame: 6 months
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 31 Mar 2022.
- Individual participant dataSharing planned: Yes. The individual data will be available in this report after deidenttification (text, tables, figures and appendices) to those researchers who provide a methodologically sound proposal and for meta-analysis.
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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.
alejandro martin-malo, MD principal investigator
Maimónides Biomedical Research Institute of Córdoba
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing on-line hemodiafiltration in people with Chronic Kidney Disease Requiring Chronic Dialysis, run by Maimónides Biomedical Research Institute of Córdoba at 2 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 2 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 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Effect of two different dialysis modalities (high flux vs online hemodiafiltration) on endothelial function markers: CD31,CD41,CD34; as measured by the percent of labeled cells obtained by flow cytometry. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2022.