Chronic Kidney FailurePhase 1/2NCT03202212
Effect of Mixed On-line Hemodiafiltration on Circulating Markers of Inflammation and Vascular Dysfunction
A Phase 1/2 study testing mixed on-line hemodiafiltration and High flux bicarbonate dialysis in people with Chronic Kidney Failure and Dialysis Related Complication, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
Trial summary
On line haemodiafiltration (OL-HDF) has been shown to improve intra-dialytic hemodynamics and cardiovascular outcomes. Several potential candidates of these beneficial effects have been explored. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Failure, Dialysis Related Complication
- What is being tested?
- mixed on-line hemodiafiltration and High flux bicarbonate dialysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 3 Feb 2014to 11 Nov 2014
- Phase
- Phase 1/2
- 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
- hemodialytic treatment from at least 6 months (3 times for week), blood flow rate during dialysis session (Qb) ≥250 ml/min using arterovenous fistula (AVF) or permanent central venous catheter (CVC), blood creatinine clearance <5 ml/min, urine output <500 ml/die.
Who cannot join
- neoplastic diseases, autoimmune diseases, solid organ or bone marrow transplantation
Trial locations and contacts
1 site in 1 country.
Italy1 site
Città della Salute e Della Scienza di Torino - Presidi CTO e Molinette
Torino, To, 10126
About this study
On line haemodiafiltration (OL-HDF) has been shown to improve intra-dialytic hemodynamics and cardiovascular outcomes. Several potential candidates of these beneficial effects have been explored. The aim of this study was to investigate the impact of mixed OL-HDF (mOL-HDF) on different circulating mediators of vascular dysfunction.
Read the detailed description
This is an open label placebo-controlled randomized clinical trial to assess the effect of mixed OL-HDF (mOL-HDF) on different circulating mediators of vascular dysfunction.
Inclusion criteria: age > 18 yrs, hemodialytic treatment from at least 6 months (3 times for week), blood flow rate (Qb) ≥ 250 ml/min using arterovenous fistula (AVF) or permanent central venous catheter (CVC), blood creatinine clearance <5 ml/min, urine output<500 ml/die.
Exclusion criteria: neoplastic diseases, chronic autoimmune diseases, lack of consent, solid organ or bone marrow transplantation.
Safety Assessment: the use of mOL-HDF has been approved by the European Medicines Agency as routine hemodepurative technique for end stage renal disease patients. Patients were evaluated for adverse reaction at each dialysis section; investigators recorded intra and extra-dialytic adverse events.
Study Treatment, Dosage, and Route of Administration: Enrolled patients have been randomized in 2 groups: 15 patients continued high flux bicarbonate hemodialysis (BHD), whereas 15 patients switched to mixed on-line hemodiafiltration (mOL-HDF using FX 1000 CorDiax, Fresenius Medical Care, Bad Homburg, Germany) for 9 months.
Efficacy Assessments:
Main outcome variable: changes in RNA content of circulating exosome/microvesicles (at 9 months) Secondary outcomes: changes in circulating inflammatory markers (C-Reactive Protein, Neutrophil Gelatinase Associated Lipocalin, Interleukin-6, Ferritin) at 3-6 and 9 months. changes in RNA content of circulating microvesicles (at 3 and 6 months)
Study Duration: 9 months
Statistical Methods: Data have been analyzed according to an intention-to-treat approach. Statistical analysis was performed using the unpaired Student t -test, ANOVA, or Kruskal-Wallis test when appropriate. A two-sided value of p=0.05 was considered significant.
- Being tested
- mixed on-line hemodiafiltration, High flux bicarbonate dialysis
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mixed on-line hemodiafiltrationProcedure or surgery
This is a mixed hemodepurative technique exploiting diffusion and convection through a semi-permeable membrane. Dialysis solution is not only interfacing with blood through the membrane (as in bicarbonate hemodialysis) but it is also mixed with it with a pre- and a post- filter dilution. The same amount of fluid added to the bloodstream is then removed within the filter through an appropriate negative pressure in the dialysis solution compartment and thanks a high permeability membrane. Patients will be treated three sessions per week, four hours per session
High flux bicarbonate dialysisProcedure or surgery
Standard high flux bicarbonate dialysis with polysulfone membrane, three sessions per week, four hours per session
| Study group | Role | What they receive |
|---|---|---|
| Mixed on-line hemodiafiltration | Experimental | Mixed on-line hemodiafiltration (mOL-HDF using FX 1000 CorDiax, Fresenius Medical Care, Bad Homburg, Germany), three sessions per week, four hours per session Receives: Procedure: mixed on-line hemodiafiltration |
| High flux bicarbonate dialysis | Active comparator | Standard high flux bicarbonate dialysis with polysulfone membrane, three sessions per week, four hours per session Receives: Procedure: High flux bicarbonate dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
RNA content of circulating particles
Quantitative micro-RNA changes in plasmatic exosomes/microvesicles assessed by quantitative real-time PCR
Measured: Study start (time 0) and study end (9 months)
Secondary outcomes (2)
Circulating inflammatory markers
Quantitative changes in C-Reactive Protein, Neutrophil Gelatinase Associated Lipocalin, Interleukin-6, Ferritin
Measured: All the study timepoints: time 0 and 3, 6, 9 months
RNA content of circulating particles
Quantitative micro-RNA changes in plasmatic exosomes/microvesicles assessed by quantitative real-time PCR
Measured: All the study timepoints: time 0 and 3, 6, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start3 Feb 2014
- Primary completion10 Feb 2014
- Study completion11 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 30 patients treated with a standard 3-time per week bicarbonate high-flux hemodialysis will be randomized 1:1 to continue the treatment or to be switched to mixed on-line hemodiafiltration for 9 months
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincenzo Cantaluppi, A.O.U. Città della Salute e della Scienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202212
- Sponsor's protocol ID
- 0030959 CEI/568
- Status last verified
- Jun 2017
- First submitted
- 8 Jun 2017
- Last updated
- 29 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the time of registration the study was already completed. IPD data will be available upon request till the study publication, then data will be enclosed within the publication as supplementary material.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mixed On-line Hemodiafiltration on Circulating Markers of Inflammation and Vascular Dysfunction
- ClinicalTrials.gov ID
- NCT03202212
- Acronym / sponsor ID
- 0030959 CEI/568
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Study start
- 3 Feb 2014 (actual)
- Primary completion
- 10 Feb 2014 (actual)
- Study completion
- 11 Nov 2014 (actual)
- First posted
- 28 Jun 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.
On line haemodiafiltration (OL-HDF) has been shown to improve intra-dialytic hemodynamics and cardiovascular outcomes. Several potential candidates of these beneficial effects have been explored. The aim of this study was to investigate the impact of mixed OL-HDF (mOL-HDF) on different circulating mediators of vascular dysfunction.
Detailed description
This is an open label placebo-controlled randomized clinical trial to assess the effect of mixed OL-HDF (mOL-HDF) on different circulating mediators of vascular dysfunction.
Inclusion criteria: age > 18 yrs, hemodialytic treatment from at least 6 months (3 times for week), blood flow rate (Qb) ≥ 250 ml/min using arterovenous fistula (AVF) or permanent central venous catheter (CVC), blood creatinine clearance <5 ml/min, urine output<500 ml/die.
Exclusion criteria: neoplastic diseases, chronic autoimmune diseases, lack of consent, solid organ or bone marrow transplantation.
Safety Assessment: the use of mOL-HDF has been approved by the European Medicines Agency as routine hemodepurative technique for end stage renal disease patients. Patients were evaluated for adverse reaction at each dialysis section; investigators recorded intra and extra-dialytic adverse events.
Study Treatment, Dosage, and Route of Administration: Enrolled patients have been randomized in 2 groups: 15 patients continued high flux bicarbonate hemodialysis (BHD), whereas 15 patients switched to mixed on-line hemodiafiltration (mOL-HDF using FX 1000 CorDiax, Fresenius Medical Care, Bad Homburg, Germany) for 9 months.
Efficacy Assessments:
Main outcome variable: changes in RNA content of circulating exosome/microvesicles (at 9 months) Secondary outcomes: changes in circulating inflammatory markers (C-Reactive Protein, Neutrophil Gelatinase Associated Lipocalin, Interleukin-6, Ferritin) at 3-6 and 9 months. changes in RNA content of circulating microvesicles (at 3 and 6 months)
Study Duration: 9 months
Statistical Methods: Data have been analyzed according to an intention-to-treat approach. Statistical analysis was performed using the unpaired Student t -test, ANOVA, or Kruskal-Wallis test when appropriate. A two-sided value of p=0.05 was considered significant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 30 patients treated with a standard 3-time per week bicarbonate high-flux hemodialysis will be randomized 1:1 to continue the treatment or to be switched to mixed on-line hemodiafiltration for 9 months
| Arm | Type | Receives |
|---|---|---|
| Mixed on-line hemodiafiltration | Experimental | Procedure: mixed on-line hemodiafiltrationMixed on-line hemodiafiltration (mOL-HDF using FX 1000 CorDiax, Fresenius Medical Care, Bad Homburg, Germany), three sessions per week, four hours per session |
| High flux bicarbonate dialysis | Active comparator | Procedure: High flux bicarbonate dialysisStandard high flux bicarbonate dialysis with polysulfone membrane, three sessions per week, four hours per session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- hemodialytic treatment from at least 6 months (3 times for week), blood flow rate during dialysis session (Qb) ≥250 ml/min using arterovenous fistula (AVF) or permanent central venous catheter (CVC), blood creatinine clearance <5 ml/min, urine output <500 ml/die.
Key exclusion criteria (1 listed)
- neoplastic diseases, autoimmune diseases, solid organ or bone marrow transplantation
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 |
|---|---|---|
| mixed on-line hemodiafiltrationThis is a mixed hemodepurative technique exploiting diffusion and convection through a semi-permeable membrane. Dialysis solution is not only interfacing with blood through the membrane (as in bicarbonate hemodialysis) but it is also mixed with it with a pre- and a post- filter dilution. The same amount of fluid added to the bloodstream is then removed within the filter through an appropriate negative pressure in the dialysis solution compartment and thanks a high permeability membrane. Patients will be treated three sessions per week, four hours per session | Procedure or surgery | Mixed on-line hemodiafiltration |
| High flux bicarbonate dialysisStandard high flux bicarbonate dialysis with polysulfone membrane, three sessions per week, four hours per session | Procedure or surgery | High flux bicarbonate dialysis |
Primary outcome
RNA content of circulating particles
Time frame: Study start (time 0) and study end (9 months)
Quantitative micro-RNA changes in plasmatic exosomes/microvesicles assessed by quantitative real-time PCR
2 secondary outcomes
Circulating inflammatory markers
Time frame: All the study timepoints: time 0 and 3, 6, 9 months
RNA content of circulating particles
Time frame: All the study timepoints: time 0 and 3, 6, 9 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 29 Jun 2017.
- Individual participant dataSharing planned: Yes. At the time of registration the study was already completed. IPD data will be available upon request till the study publication, then data will be enclosed within the publication as supplementary material.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing mixed on-line hemodiafiltration and High flux bicarbonate dialysis in people with Chronic Kidney Failure and Dialysis Related Complication, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
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 1 inclusion and 1 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 29 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
RNA content of circulating particles (time frame: Study start (time 0) and study end (9 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 29 Jun 2017.