Chronic Renal FailureHEPADIALNCT01066559
Improvement of Humoral Immune Response With Hemodialysis on BK-F Membrane: Correlation to Soluble CD40 Clearing
A study testing High flux polymethylmetacrylate membrane, Polysulfone membrane and Seric sCD40 level in people with Chronic Renal Failure and Humoral Immune Alterations, run by University Hospital, Bordeaux at 6 sites in France.
Trial summary
The aim of this study is to improve the humoral immune response efficiency of hemodialyzed patient by the use of PMMA membrane (BK-F) able to clear the soluble form of CD40 in a model of anti-HBV vaccination Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Renal Failure, Humoral Immune Alterations
- What is being tested?
- High flux polymethylmetacrylate membrane, Polysulfone membrane and Seric sCD40 level
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 6 sitesFrance
- Study dates
- Apr 2010to Jan 2015
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years, male or female
- Patient not immunized against hepatitis B despite complete well done anterior vaccination according to recommendations
- Hemodialyzed patients with hemodialysed sessions performed three times a week
- Patient able to give informed consent and affiliated to the medical insurance
Who cannot join
- Pregnant woman
- Patient never vaccinated against HBV
- Previous known hepatitis B even without anti HBs antibody (anti HBc antibody or HBs antigenemia positive)
- Active neoplasia or plasma cell dyscrasia
- VIH infection
- Known allergy to vaccine or to PMMA membrane
Show all 10Show fewer
- Patient dialysed with PMMA membrane within three months before screening
- Necessity of acetate free biofiltration or hemodiafiltration as the technique of extrarenal epuration
- Vascular access problem with necessity of unipuncture for more than 30% of dialysis sessions.
- Patient under judicial protection
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CH Annonay
Annonay
CH de la côte Basque
Bayonne, 64100
CHU de Besançon
Besançon, 25000
Saint-Augustin Clinic, Dialyze Unit
Bordeaux, 33000
Pellegrin Hospital, Nephrology Unit
Bordeaux, 33076
Larrey Hospital, Dialyze Unit
Toulouse, 31059
About this study
Official title: Multicentric Randomized Trial of the Impact of Hemodialysis With Polymethylmetacrylate Membrane on the Improvement of Humoral Immune Response in the Hemodialyzed Patients: Application to Hepatitis B Vaccination and Correlation to sCD40 Clearing
The aim of this study is to improve the humoral immune response efficiency of hemodialyzed patient by the use of PMMA membrane (BK-F) able to clear the soluble form of CD40 in a model of anti-HBV vaccination
Read the detailed description
Chronic renal failure is associated with humoral immune alterations characterized by a diminished vaccine response notably against hepatitis B virus (HBV). Defects in cellular contact between immunological cells have been hypothesized to explain this observation but the precise mechanism leading to this "immunocompromised" status is not clear. The soluble form of CD40 (sCD40) is dramatically increased in the serum of uremic patients, particularly in the hemodialyzed patients. This molecule acts like an inhibitor of the CD40/CD154 contact, which is pivotal in the establishment of a proper humoral immune response. It has been shown that the most elevated sCD40 levels are associated with a lack of response to HBV vaccination in the hemodialyzed patients. The majority of the hemodialysis membranes, including high flux polysulfone membranes are unable to clear sCD40 from the sera. However, we found that the high flux polymethylmetacrylate (PMMA) membrane (BK-F Toray Medical Company, Japan) allows for sCD40 clearing.
The aim of this study is to assess the effect of dialysis on PMMA membrane on the improvement of humoral immune response through the efficiency of HBV vaccination in hemodialysed patients who were non responders to one ore more previous vaccination and its link to sCD40 clearing.
- Conditions
- Chronic Renal Failure, Humoral Immune Alterations
- Being tested
- High flux polymethylmetacrylate membrane, Polysulfone membrane, Hepatitis B serological control, Seric sCD40 level
- 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.
High flux polymethylmetacrylate membraneProcedure or surgery
Patients will be hemodialysed with high flux polymethylmetacrylate membranes
Polysulfone membraneProcedure or surgery
Patients be hemodialysed with polysulfone membranes
Hepatitis B serological controlBiological
It will be assessed at week 16, week 20 and week 40
Seric sCD40 levelBiological
Ir will be measured at inclusion and week 12 by ELISA test according to the manufacturer instructions.
| Study group | Role | What they receive |
|---|---|---|
| High flux polymethylmetacrylate membrane | Experimental | Not described Receives: Procedure: High flux polymethylmetacrylate membrane; Biological: Hepatitis B serological control; Biological: Seric sCD40 level |
| Polysulfone membranes | Active comparator | Not described Receives: Procedure: Polysulfone membrane; Biological: Hepatitis B serological control; Biological: Seric sCD40 level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who will respond to vaccination
Measured: Week 40
Secondary outcomes (3)
Percentage and the level of anti-HBs antibodies
Measured: at week 16, week 20, week 24 and week 40
Correlation between the sCD40 levels and the response to HBV vaccination
Measured: At week 12 and week 40
Correlation between albuminemia, C-Reactive Protein, lymphocytes, parathyroid hormone, chronic immunosuppressive treatment or corticoid taking and vaccinal response.
Measured: at week 12, week 24, and week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2010 (estimated)
- Study startApr 2010
- Primary completionJan 2015
- Study completionJan 2015
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 Chronic Renal FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie de PRECIGOUT, MD, Principal investigator, University Hospital, Bordeaux, FrancePierre BORIES, MD, Principal investigator, University Hospital, Toulouse, FranceMichel RINCE, MD, Principal investigator, University Hospital, Limoges, FranceCaroline DELCLAUX, MD, Principal investigator, Hospital, Libourne, FranceAntoine POMMEREAU, MD, Principal investigator, Clinic Saint-Augustin, Bordeaux, FranceBenjamin DEROURE, MD, Principal investigator, Clinic Delay, Bayonne, FranceHervé BONAREK, MD, Principal investigator, Hospital, Saintes, FranceAntoine BENARD, MD, Study chair, University Hospital, Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01066559
- Sponsor's protocol ID
- CHUBX 2009/11
- Acronym
- HEPADIAL
- Status last verified
- Jun 2015
- First submitted
- 9 Feb 2010
- Last updated
- 25 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
de Precigout V, Germain C, Benard A, Lacraz A, Chauveau P, Deprele C, Seigneuric B, Pommereau A, Courivaud C, Douillet M, Taton B, Combe C, Contin-Bordes C. No Improvement of Hepatitis B Vaccination Response in Patients Dialysed with a Polymethylmethacrylate Membrane Compared to High-Flux Polysulfone: Results of the HEPADIAL Study. Blood Purif. 2020;49(3):265-271. doi: 10.1159/000504035. Epub 2019 Nov 13.
PubMed 31722332
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Randomized Trial of the Impact of Hemodialysis With Polymethylmetacrylate Membrane on the Improvement of Humoral Immune Response in the Hemodialyzed Patients: Application to Hepatitis B Vaccination and Correlation to sCD40 Clearing
- ClinicalTrials.gov ID
- NCT01066559
- Acronym / sponsor ID
- HEPADIAL / CHUBX 2009/11
- Conditions
- Chronic Renal Failure, Humoral Immune Alterations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 10 Feb 2010 (estimated)
- 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 aim of this study is to improve the humoral immune response efficiency of hemodialyzed patient by the use of PMMA membrane (BK-F) able to clear the soluble form of CD40 in a model of anti-HBV vaccination
Detailed description
Chronic renal failure is associated with humoral immune alterations characterized by a diminished vaccine response notably against hepatitis B virus (HBV). Defects in cellular contact between immunological cells have been hypothesized to explain this observation but the precise mechanism leading to this "immunocompromised" status is not clear. The soluble form of CD40 (sCD40) is dramatically increased in the serum of uremic patients, particularly in the hemodialyzed patients. This molecule acts like an inhibitor of the CD40/CD154 contact, which is pivotal in the establishment of a proper humoral immune response. It has been shown that the most elevated sCD40 levels are associated with a lack of response to HBV vaccination in the hemodialyzed patients. The majority of the hemodialysis membranes, including high flux polysulfone membranes are unable to clear sCD40 from the sera. However, we found that the high flux polymethylmetacrylate (PMMA) membrane (BK-F Toray Medical Company, Japan) allows for sCD40 clearing.
The aim of this study is to assess the effect of dialysis on PMMA membrane on the improvement of humoral immune response through the efficiency of HBV vaccination in hemodialysed patients who were non responders to one ore more previous vaccination and its link to sCD40 clearing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High flux polymethylmetacrylate membrane | Experimental | Procedure: High flux polymethylmetacrylate membrane, Biological: Hepatitis B serological control, Biological: Seric sCD40 level |
| Polysulfone membranes | Active comparator | Procedure: Polysulfone membrane, Biological: Hepatitis B serological control, Biological: Seric sCD40 level |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 80 years, male or female
- Patient not immunized against hepatitis B despite complete well done anterior vaccination according to recommendations
- Hemodialyzed patients with hemodialysed sessions performed three times a week
- Patient able to give informed consent and affiliated to the medical insurance
Key exclusion criteria (10 listed)
- Pregnant woman
- Patient never vaccinated against HBV
- Previous known hepatitis B even without anti HBs antibody (anti HBc antibody or HBs antigenemia positive)
- Active neoplasia or plasma cell dyscrasia
- VIH infection
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 |
|---|---|---|
| High flux polymethylmetacrylate membranePatients will be hemodialysed with high flux polymethylmetacrylate membranes | Procedure or surgery | High flux polymethylmetacrylate membrane |
| Polysulfone membranePatients be hemodialysed with polysulfone membranes | Procedure or surgery | Polysulfone membranes |
| Hepatitis B serological controlIt will be assessed at week 16, week 20 and week 40 | Biological | High flux polymethylmetacrylate membrane, Polysulfone membranes |
| Seric sCD40 levelIr will be measured at inclusion and week 12 by ELISA test according to the manufacturer instructions. | Biological | High flux polymethylmetacrylate membrane, Polysulfone membranes |
Primary outcome
Percentage of patients who will respond to vaccination
Time frame: Week 40
3 secondary outcomes
Percentage and the level of anti-HBs antibodies
Time frame: at week 16, week 20, week 24 and week 40
Correlation between the sCD40 levels and the response to HBV vaccination
Time frame: At week 12 and week 40
Correlation between albuminemia, C-Reactive Protein, lymphocytes, parathyroid hormone, chronic immunosuppressive treatment or corticoid taking and vaccinal response.
Time frame: at week 12, week 24, and week 36
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 25 Jun 2015.
- Derived from this study: PubMed 31722332de Precigout V, Germain C, Benard A, Lacraz A, Chauveau P, Deprele C, Seigneuric B, Pommereau A, Courivaud C, Douillet M, Taton B, Combe C, Contin-Bordes C. No Improvement of Hepatitis B Vaccination Response in Patients Dialysed with a Polymethylmethacrylate Membrane Compared to High-Flux Polysulfone: Results of the HEPADIAL Study. Blood Purif. 2020;49(3):265-271. doi: 10.1159/000504035. Epub 2019 Nov 13.
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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.
Valérie de PRECIGOUT, MD principal investigator
University Hospital, Bordeaux, France
Pierre BORIES, MD principal investigator
University Hospital, Toulouse, France
Michel RINCE, MD principal investigator
University Hospital, Limoges, France
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High flux polymethylmetacrylate membrane, Polysulfone membrane and Seric sCD40 level in people with Chronic Renal Failure and Humoral Immune Alterations, run by University Hospital, Bordeaux at 6 sites in France.
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 10 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 25 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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?
Percentage of patients who will respond to vaccination (time frame: Week 40). 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 NCT01066559, 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 25 Jun 2015.