End Stage Renal DiseaseTHERANOVANCT03211676
Comparison of Hemodialysis With Medium Cut-off Dialyzer (Theranova) and High Flux Dialyzer
A study testing Theranova-500 dialyzer and Elisio-21H in people with End Stage Renal Disease and Dialysis Related Complication, run by Poitiers University Hospital at 1 site in France.
Trial summary
The aim of this study is to evaluate the removal of midle molecules and inflammatory cytokines with the Theranova-500 ™ dialyzer (medium cut-off membrane, Baxter®) versus a high flux dialyzer Elisio-21H ™ (High-flux membrane, Nipro®) in chronic hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Dialysis Related Complication, Dialysis Amyloidosis
- What is being tested?
- Theranova-500 dialyzer and Elisio-21H
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jun 2017to 14 Jun 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
- Age ≥ 18 years
- Patient suffering from chronic terminal renal failure excluding nephropathy with myelomatous cylinders, hemodialysis for more than 6 months,
- Patient under dialyser Elisio-21H ™ for more than 3 months
- Patient including the protocol scheme and able to comply with it
- Free subject, without guardianship or curatorship or subordination
- Patients benefiting from a Social Security scheme or benefiting from it through a third party
- Non-opposition given by the patient after clear and fair information on the study
Who cannot join
- Age <18 years
- Patient with an associated pathology (evolutionary cancer, progressive infectious disease or chronic inflammatory disease) that may excessively influence CRP levels (CRP> 60 mg / L)
- Patient following another protocol of research or period of exclusion of another protocol
- Patients not benefiting from a Social Security scheme or not benefiting from it through a third party
- Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, and finally patients in emergencies .
- Pregnant or nursing women, women of childbearing age who do not have effective contraception (hormonal / mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total ovariectomy ).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Hemodialysis With Medium Cut-off Dialyzer (Theranova) and High Flux Dialyzer on Removal of Small and Middle Size Molecules, Inflammatory Parameters and Oxidative Stress. An Open Cross Over Randomized Study
The aim of this study is to evaluate the removal of midle molecules and inflammatory cytokines with the Theranova-500 ™ dialyzer (medium cut-off membrane, Baxter®) versus a high flux dialyzer Elisio-21H ™ (High-flux membrane, Nipro®) in chronic hemodialysis.
Evaluation of nutritional parameters, inflamatory parameters and oxidative stress will also be carried out.
Finally, the investigators will compare hepcidin levels and the erythropoietin resistance index between the two groups.
- Being tested
- Theranova-500 dialyzer, Elisio-21H
- Keywords
- dialyzer, beta2-microglobilin, myoglobin
- 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.
Theranova-500 dialyzerDevice
hemodialysis with Theranova-500 dialyzer.
Elisio-21HDevice
hemodialysis with Elisio-21H dialyzer
| Study group | Role | What they receive |
|---|---|---|
| Theranova-500 | Active comparator | Not described Receives: Device: Theranova-500 dialyzer; Device: Elisio-21H |
| Elisio-21H | Sham comparator | Not described Receives: Device: Theranova-500 dialyzer; Device: Elisio-21H |
What is being measured
The primary outcome is the main question the study is designed to answer.
Removal of myoglobin
myoglobin Reduction ratio.
Measured: After 3 months
Secondary outcomes (26)
Removal of beta2 microglobulin
Reduction rate and clearances of beta2 microglobulin
Measured: After 3 months
Removal of urea
Reduction ratio and clearances of urea
Measured: After 3 months
Removal of creatinine
Reduction ratio and clearances of creatinine
Measured: After 3 months
Removal of interleukin 6
Reduction ratio and clearances of interleukin 6
Measured: After 3 months
Removal of IL-1beta
Reduction ratio and clearances of IL-1beta
Measured: After 3 months
Removal of TNF alpha
Reduction ratio and clearances of TNF alpha
Measured: After 3 months
Removal of leptin
Reduction ratio and clearances of leptin
Measured: After 3 months
Removal of alpha 1 microglobulin
Reduction ratio and clearances of alpha 1 microglobulin
Measured: After 3 months
Removal of retinol binding protein
Reduction ratio and clearances of retinol binding protein
Measured: After 3 months
Removal of hyaluronic acid
Reduction ratio and clearances of hyaluronic acid
Measured: After 3 months
Removal of FGF 23 (fibroblast growth factor 23)
Reduction ratio and clearances of FGF 23
Measured: After 3 months
Removal of prolactin
Reduction ratio and clearances of prolactin
Measured: After 3 months
Removal of free light chain kappa
Reduction ratio and clearances of free light chain kappa
Measured: After 3 months
Removal of free light chain lambda
Reduction ratio and clearances of free light chain lambda
Measured: After 3 months
comparison of pre dialysis level of hepcidin
comparison of average of pre dialysis level of hepcidin
Measured: After 3 months
comparison of pre dialysis level of superoxide dismutase
comparison of average of pre dialysis level of superoxide dismutase
Measured: After 3 months
comparison of pre dialysis level of isoprostan
comparison of average of pre dialysis level of isoprostan
Measured: After 3 months
comparison of pre dialysis level of human oxidized LDL
comparison of average of pre dialysis level of human oxidized LDL
Measured: After 3 months
comparison of pre dialysis level of albumin
comparison of average of pre dialysis level of albumin
Measured: After 3 months
comparison of pre dialysis level of prealbumin
comparison of average of pre dialysis level of prealbumin
Measured: After 3 months
comparison of post dialysis level of albumin
comparison of average of post dialysis level of albumin
Measured: After 3 months
comparison of level of middle molecules and albumin in the dialysate
comparison of average level of midlle molecules and albumin in dialysate
Measured: After 3 months
comparison of use of erythrpoietin
Comparison of the erythropoietin resistance index
Measured: After 3 months
comparison of hemoglobin levels
comparison of average of predialysis hemoglobin levels
Measured: After 3 months
comparison of pre dialysis level of CRP
comparison of average of pre dialysis level of CRP
Measured: After 3 months
comparison of pre dialysis level of SAA
comparison of average of pre dialysis level of SAA
Measured: After 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start7 Jun 2017
- Primary completion14 Mar 2018
- Study completion14 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Mohamed BELMOUAZ, Principal investigator, Poitiers University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211676
- Sponsor's protocol ID
- 2016-A01679-42
- Acronym
- THERANOVA
- Status last verified
- Apr 2020
- First submitted
- 18 May 2017
- Last updated
- 13 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hemodialysis With Medium Cut-off Dialyzer (Theranova) and High Flux Dialyzer on Removal of Small and Middle Size Molecules, Inflammatory Parameters and Oxidative Stress. An Open Cross Over Randomized Study
- ClinicalTrials.gov ID
- NCT03211676
- Acronym / sponsor ID
- THERANOVA / 2016-A01679-42
- Keywords
- dialyzer, beta2-microglobilin, myoglobin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 7 Jun 2017 (actual)
- Primary completion
- 14 Mar 2018 (actual)
- Study completion
- 14 Jun 2018 (actual)
- First posted
- 7 Jul 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.
The aim of this study is to evaluate the removal of midle molecules and inflammatory cytokines with the Theranova-500 ™ dialyzer (medium cut-off membrane, Baxter®) versus a high flux dialyzer Elisio-21H ™ (High-flux membrane, Nipro®) in chronic hemodialysis.
Evaluation of nutritional parameters, inflamatory parameters and oxidative stress will also be carried out.
Finally, the investigators will compare hepcidin levels and the erythropoietin resistance index between the two groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Theranova-500 | Active comparator | Device: Theranova-500 dialyzer, Device: Elisio-21H |
| Elisio-21H | Sham comparator | Device: Theranova-500 dialyzer, Device: Elisio-21H |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Patient suffering from chronic terminal renal failure excluding nephropathy with myelomatous cylinders, hemodialysis for more than 6 months,
- Patient under dialyser Elisio-21H ™ for more than 3 months
- Patient including the protocol scheme and able to comply with it
- Free subject, without guardianship or curatorship or subordination
Key exclusion criteria (6 listed)
- Age <18 years
- Patient with an associated pathology (evolutionary cancer, progressive infectious disease or chronic inflammatory disease) that may excessively influence CRP levels (CRP> 60 mg / L)
- Patient following another protocol of research or period of exclusion of another protocol
- Patients not benefiting from a Social Security scheme or not benefiting from it through a third party
- Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, and finally patients in emergencies .
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 |
|---|---|---|
| Theranova-500 dialyzerhemodialysis with Theranova-500 dialyzer. | Device | Elisio-21H, Theranova-500 |
| Elisio-21Hhemodialysis with Elisio-21H dialyzer | Device | Elisio-21H, Theranova-500 |
Primary outcome
Removal of myoglobin
Time frame: After 3 months
myoglobin Reduction ratio.
26 secondary outcomes
Removal of beta2 microglobulin
Time frame: After 3 months
Removal of urea
Time frame: After 3 months
Removal of creatinine
Time frame: After 3 months
Removal of interleukin 6
Time frame: After 3 months
Removal of IL-1beta
Time frame: After 3 months
Removal of TNF alpha
Time frame: After 3 months
Removal of leptin
Time frame: After 3 months
Removal of alpha 1 microglobulin
Time frame: After 3 months
Removal of retinol binding protein
Time frame: After 3 months
Removal of hyaluronic acid
Time frame: After 3 months
Removal of FGF 23 (fibroblast growth factor 23)
Time frame: After 3 months
Removal of prolactin
Time frame: After 3 months
Removal of free light chain kappa
Time frame: After 3 months
Removal of free light chain lambda
Time frame: After 3 months
comparison of pre dialysis level of hepcidin
Time frame: After 3 months
comparison of pre dialysis level of superoxide dismutase
Time frame: After 3 months
comparison of pre dialysis level of isoprostan
Time frame: After 3 months
comparison of pre dialysis level of human oxidized LDL
Time frame: After 3 months
comparison of pre dialysis level of albumin
Time frame: After 3 months
comparison of pre dialysis level of prealbumin
Time frame: After 3 months
comparison of post dialysis level of albumin
Time frame: After 3 months
comparison of level of middle molecules and albumin in the dialysate
Time frame: After 3 months
comparison of use of erythrpoietin
Time frame: After 3 months
comparison of hemoglobin levels
Time frame: After 3 months
comparison of pre dialysis level of CRP
Time frame: After 3 months
comparison of pre dialysis level of SAA
Time frame: After 3 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 13 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Mohamed BELMOUAZ principal investigator
Poitiers University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theranova-500 dialyzer and Elisio-21H in people with End Stage Renal Disease and Dialysis Related Complication, run by Poitiers University Hospital 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 6 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 13 Apr 2020. 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. Some participants in this study may receive a placebo. 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?
Removal of myoglobin (time frame: After 3 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 13 Apr 2020.