End Stage Renal DiseaseBIOMODALNCT03262272
Evaluation of Biocompatibility and Performances of 4 Dialyzers in Different Mode Treatments
A study testing VIE A Hemodialyzer, Rexsys 27H hemodialyzer and Leoceed 21HX hemodialyzer in people with End Stage Renal Disease and Inflammation, run by Hemotech at 1 site in France.
Trial summary
Prospective multicenter randomized cross-over study Number of patients : 32 (8 patients per group) Obtain objectives data to advise each hemodialyzer according to dialysis treatment and patient profile. To evaluate the different hemodialyzers and judge their extraction performances in HD and post HDF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Inflammation
- What is being tested?
- VIE A Hemodialyzer, Rexsys 27H hemodialyzer and Leoceed 21HX hemodialyzer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 21 Nov 2016to 31 Oct 2018
- 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
- Adult patient with chronic kidney disease dialyzed for at least one month and treated with the treatment mode that we will test
- Patient using post-dilution HDF mode have to use EuDIAL volume guidelines (20-22L minimum)
- Patient treated before with high permeability membrane
- Patient with vascular access allowing a blood flow rate with a minimum of 300 mL/min
- Patient treated with a high surface area dialyzer ≥ 1,8 m²
- Patient covered by the social French health organism
- Patient informed of the study goals and having signed the informed consent
Who cannot join
- Patient with a vascular access not allowing a blood flow rate minimum of 300 mL/min
- Patient with a fast progressive chronic disease
- Patient with an uncontrolled anemia
- Patient refusing to sign the informed consent
- Pregnant or nursing patient
- Pediatric patient
- Patient under tutorship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Dialyzers' Biocompatibility and Performances Compared in Different Dialysis Treatments : Conventional Hemodialysis and Post-dilution Hemodialfiltration
Prospective multicenter randomized cross-over study Number of patients : 32 (8 patients per group) Obtain objectives data to advise each hemodialyzer according to dialysis treatment and patient profile.
To evaluate the different hemodialyzers and judge their extraction performances in HD and post HDF.
Evaluation of the biocompatibility of the hemodialyzers and the patients' inflammatory status.
Read the detailed description
Medical devices studied :
- Leoceed 21HX, hemodialyzer, High permeability PS membrane 2,1 m² , made by Nx Stage in Germany
- Polypure 22S, hemodialyzer, High permeability PS membrane 2,2 m² , made by Allmed in Germany
- VIE 21A hemodialyzer, High permeability PS membrane 2,1 m² coated in vitamin E, made by Asahi Kasei Medical in Japan
- Rexsys 27H, hemodialyzer , High permeability PES membrane 2,7 m² , made by Medica in Italia
These hemodialyzers are EC marked and are used in their own indications.
Schema
Details of the cross-over plan :
8 patients will be treated successively with the 4 hemodialyzers. Patients will be treated with the dialyzer "test" for the two first sessions of the week. During the last dialysis session of each week, only their usual dialyzer will be used as wash-out. A randomization will define the order of use of the dialyzers in the 4 centers. This order will be identical in a center.
Number of patients :
32 (8 patients per center (4 centers))
Duration :
One week per dialyzer
- Conditions
- End Stage Renal Disease, Inflammation
- Being tested
- VIE A Hemodialyzer, Rexsys 27H hemodialyzer, Leoceed 21HX hemodialyzer, Polypure 22S+ hemodialyzer
- Medical subject headings
- Kidney Failure, Chronic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIE A HemodialyzerDevice
polysulfon membrane coated with vitamin E
Rexsys 27H hemodialyzerDevice
polyethersulfon membrane with large surface area : 2,7m²
Leoceed 21HX hemodialyzerDevice
polyslfon membrane with gamma sterilization
Polypure 22S+ hemodialyzerDevice
polysulfon membrane with steam sterilization
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis | Experimental | patients treated by conventionnal hemodialysis Receives: Device: VIE A Hemodialyzer; Device: Rexsys 27H hemodialyzer; Device: Leoceed 21HX hemodialyzer; Device: Polypure 22S+ hemodialyzer |
| Hemodiafiltration post dilution | Experimental | patients treated by HDF post-dilution Receives: Device: VIE A Hemodialyzer; Device: Rexsys 27H hemodialyzer; Device: Leoceed 21HX hemodialyzer; Device: Polypure 22S+ hemodialyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of middle molecules extraction
Measurements of β 2 microglobulin (11,8kDa), myoglobin (17kDa), Beta Trace (21kDa), Free immunoglobulin light chains Kappa (23kDa), myostatin (40kDa), glycoprotein orosomucoïd (44kDa)
Measured: one week per dialyzer per patient
Secondary outcomes (8)
Extraction of uremic toxins
- Urea
- Creatinin
- inorganic phosphates
Measured: one week per dialyzer per patient
Biocompatibility assessment
- Anaphylatoxins (C3a, C5a) during the session (T0, T15, Tend)
- TNF-α and IL-6 (T0 et Tend)
Measured: one week per dialyzer per patient
Monitoring of Nutrition status
Quantification of the albumin loss in the used dialysate (1 center) during the middle session of the week for each dialyzer tested per patient, i.e 4 times/patient.
2 analysis modalities will be used: " pull and push " syringe Plastipak BD 50mL or collection of the whole dialysate in a 200 L tank
Dosage Albumin et pre-albumin before dialysis session
Measured: one week per dialyzer per patient
Handling of the devices
- Evaluation of the priming and recovery for each dialysis session
Measured: one week per dialyzer per patient
Dialysis adequacy evaluation
Calculation of KT/V
Measured: one week per dialyzer per patient
Session tolerance
All secondary troubles will be noted: cramps, nauseas, hypotension…
Measured: one week per dialyzer per patient
Parameters inflammation
CRP (mg/l)
Measured: one week per dialyzer per patient
Parameters inflammation
- Calcul of PINI = [CRP(mg/l) x Orosomucoïd (mg/l)] / [Albumin(g/l) x Pre-albumin(mg/l)]
Measured: one week per dialyzer per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start21 Nov 2016
- Primary completion31 Jul 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective randomized cross-over study
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hemotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean Paul CRISTOL, Professor, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262272
- Sponsor's protocol ID
- BIOMODAL 2016-A01122-49
- Acronym
- BIOMODAL
- Status last verified
- Feb 2019
- First submitted
- 12 Jul 2017
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kokubo K, Kurihara Y, Kobayashi K, Tsukao H, Kobayashi H. Evaluation of the Biocompatibility of Dialysis Membranes. Blood Purif. 2015;40(4):293-7. doi: 10.1159/000441576. Epub 2015 Nov 17.
PubMed 26656534Maduell F, Moreso F, Mora-Macia J, Pons M, Ramos R, Carreras J, Soler J, Torres F; study group ESHOL. ESHOL study reanalysis: All-cause mortality considered by competing risks and time-dependent covariates for renal transplantation. Nefrologia. 2016;36(2):156-63. doi: 10.1016/j.nefro.2015.10.007. Epub 2015 Dec 8. English, Spanish.
PubMed 26672890
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dialyzers' Biocompatibility and Performances Compared in Different Dialysis Treatments : Conventional Hemodialysis and Post-dilution Hemodialfiltration
- ClinicalTrials.gov ID
- NCT03262272
- Acronym / sponsor ID
- BIOMODAL / BIOMODAL 2016-A01122-49
- Conditions
- End Stage Renal Disease, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- HemotechIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2016 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 25 Aug 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.
Prospective multicenter randomized cross-over study Number of patients : 32 (8 patients per group) Obtain objectives data to advise each hemodialyzer according to dialysis treatment and patient profile.
To evaluate the different hemodialyzers and judge their extraction performances in HD and post HDF.
Evaluation of the biocompatibility of the hemodialyzers and the patients' inflammatory status.
Detailed description
Medical devices studied :
- Leoceed 21HX, hemodialyzer, High permeability PS membrane 2,1 m² , made by Nx Stage in Germany
- Polypure 22S, hemodialyzer, High permeability PS membrane 2,2 m² , made by Allmed in Germany
- VIE 21A hemodialyzer, High permeability PS membrane 2,1 m² coated in vitamin E, made by Asahi Kasei Medical in Japan
- Rexsys 27H, hemodialyzer , High permeability PES membrane 2,7 m² , made by Medica in Italia
These hemodialyzers are EC marked and are used in their own indications.
Schema
Details of the cross-over plan :
8 patients will be treated successively with the 4 hemodialyzers. Patients will be treated with the dialyzer "test" for the two first sessions of the week. During the last dialysis session of each week, only their usual dialyzer will be used as wash-out. A randomization will define the order of use of the dialyzers in the 4 centers. This order will be identical in a center.
Number of patients :
32 (8 patients per center (4 centers))
Duration :
One week per dialyzer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomized cross-over study
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis | Experimental | Device: VIE A Hemodialyzer, Device: Rexsys 27H hemodialyzer, Device: Leoceed 21HX hemodialyzer, Device: Polypure 22S+ hemodialyzerpatients treated by conventionnal hemodialysis |
| Hemodiafiltration post dilution | Experimental | Device: VIE A Hemodialyzer, Device: Rexsys 27H hemodialyzer, Device: Leoceed 21HX hemodialyzer, Device: Polypure 22S+ hemodialyzerpatients treated by HDF post-dilution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patient with chronic kidney disease dialyzed for at least one month and treated with the treatment mode that we will test
- Patient using post-dilution HDF mode have to use EuDIAL volume guidelines (20-22L minimum)
- Patient treated before with high permeability membrane
- Patient with vascular access allowing a blood flow rate with a minimum of 300 mL/min
- Patient treated with a high surface area dialyzer ≥ 1,8 m²
Key exclusion criteria (7 listed)
- Patient with a vascular access not allowing a blood flow rate minimum of 300 mL/min
- Patient with a fast progressive chronic disease
- Patient with an uncontrolled anemia
- Patient refusing to sign the informed consent
- Pregnant or nursing patient
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 |
|---|---|---|
| VIE A Hemodialyzerpolysulfon membrane coated with vitamin E | Device | Hemodiafiltration post dilution, Hemodialysis |
| Rexsys 27H hemodialyzerpolyethersulfon membrane with large surface area : 2,7m² | Device | Hemodiafiltration post dilution, Hemodialysis |
| Leoceed 21HX hemodialyzerpolyslfon membrane with gamma sterilization | Device | Hemodiafiltration post dilution, Hemodialysis |
| Polypure 22S+ hemodialyzerpolysulfon membrane with steam sterilization | Device | Hemodiafiltration post dilution, Hemodialysis |
Primary outcome
Evaluation of middle molecules extraction
Time frame: one week per dialyzer per patient
Measurements of β 2 microglobulin (11,8kDa), myoglobin (17kDa), Beta Trace (21kDa), Free immunoglobulin light chains Kappa (23kDa), myostatin (40kDa), glycoprotein orosomucoïd (44kDa)
8 secondary outcomes
Extraction of uremic toxins
Time frame: one week per dialyzer per patient
Biocompatibility assessment
Time frame: one week per dialyzer per patient
Monitoring of Nutrition status
Time frame: one week per dialyzer per patient
Handling of the devices
Time frame: one week per dialyzer per patient
Dialysis adequacy evaluation
Time frame: one week per dialyzer per patient
Session tolerance
Time frame: one week per dialyzer per patient
Parameters inflammation
Time frame: one week per dialyzer per patient
Parameters inflammation
Time frame: one week per dialyzer per patient
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 21 Feb 2019.
- Background: PubMed 26656534Kokubo K, Kurihara Y, Kobayashi K, Tsukao H, Kobayashi H. Evaluation of the Biocompatibility of Dialysis Membranes. Blood Purif. 2015;40(4):293-7. doi: 10.1159/000441576. Epub 2015 Nov 17.
- Background: PubMed 26672890Maduell F, Moreso F, Mora-Macia J, Pons M, Ramos R, Carreras J, Soler J, Torres F; study group ESHOL. ESHOL study reanalysis: All-cause mortality considered by competing risks and time-dependent covariates for renal transplantation. Nefrologia. 2016;36(2):156-63. doi: 10.1016/j.nefro.2015.10.007. Epub 2015 Dec 8. English, Spanish.
- Individual participant dataSharing planned: No
Related trials for End Stage Renal Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
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.
Jean Paul CRISTOL, Professor study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIE A Hemodialyzer, Rexsys 27H hemodialyzer and Leoceed 21HX hemodialyzer in people with End Stage Renal Disease and Inflammation, run by Hemotech at 1 site 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 7 inclusion and 7 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 21 Feb 2019. 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 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?
Evaluation of middle molecules extraction (time frame: one week per dialyzer per patient). 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 NCT03262272, which also lists 2 linked publications.
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 21 Feb 2019.