Renal FailureeMPORAIIINCT04714281
Comparison of Clinical Performance and Hemocompatibility of Dialyzers Applied During Post-dilution Online Hemodiafiltration
A study testing Dialyser in people with Renal Failure and End Stage Renal Disease, run by Fresenius Medical Care Deutschland GmbH at 8 sites in 3 countries.
Trial summary
Comparison of the clinical performance and the hemocompatibility profile of different high-flux dialyzers, all applied during post-dilution online hemodiafiltration Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure, End Stage Renal Disease
- What is being tested?
- Dialyser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 3 Feb 2021to 5 May 2023
- 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
- General:
- Minimum age of 18 years
- Existing informed consent form signed and dated by study patient as well as investigator/authorized physician
- The patient is legally competent and able to understand the nature, risks, meaning, and consequences of the clinical trial and can subsequently declare her/his consent for participation in the clinical trial (cf. European Medical Device Directive and corresponding national regulations)
- Patients with a chronic kidney disease stage 5D (end stage renal disease with a glomerular filtration rate of 15 ml/min or less) on hemodiafiltration as extracorporeal renal replacement therapy
- Study-specific:
- On online post-dilution hemodiafiltration (HDF), at least 4 h treatment time thrice weekly with FX or FX CorDiax dialyzer ≥ 1 month
- Vascular access (fistula or graft) which enables blood flow rate ≥ 300 ml/min
Who cannot join
- General:
- Any condition which could interfere with the patient's ability to comply with the study. This decision is at the discretion of the treating physician and relates to the general stable condition of the patient (e.g. any acute condition, e.g. infection or mental problem which might give reason for concern etc.)
- Ongoing participation in an interventional clinical study during the preceding 30 days
- Previous participation in this study
- Pregnancy (pregnancy test will be conducted at start and end of study with female patients aged < 55 years) or lactation period
- Patient is not able to give informed consent according to the European Medical Device Directive and corresponding national regulations
Show all 19Show fewer
- Study-specific:
- Recurrent episodes of vascular access failure characterized by e.g. repeated cannulation problems or unstable blood flows within the last 2 months prior to study start (>3 times, respectively)
- Repeated single needle treatments (>3 times within the last 2 months prior to study start)
- Catheter as vascular access
- Unstable patients (due to e.g. acute intercurrent disease like cardiovascular infarction, decompensated heart failure, cerebrovascular accident, severe infection, active malignant disease)
- Patients with NYHA ≥ 3, COPD (GOLD 2-4), frequent intradialytic symptomatic hypotension
- Patients with known or suspected allergy to trial product and related products
- Patients with known inborn or acquired deficiencies of the innate and/or adaptive immune system
- Patients with acute (use within last 4 weeks) and/or chronic immunosuppressive medication e.g. due to immune-mediated disease including autoimmune diseases, transplantation, or cancer (oral and systemic corticosteroids, calcineurin and mTOR-inhibitors, immunosuppressive monoclonal antibodies, cytotoxic chemotherapy)
- Planned absence from dialysis unit within the 14 weeks of study duration e.g. due to scheduled hospitalization, holidays or any other reason
- Active HBV, HCV, HIV, SARS-CoV-2 infection, as well as any other febrile illness
- Reported SARS-CoV-2 infection with or without symptoms within the 12 weeks before inclusion into the study
- Unwillingness to undergo repeated SARS-CoV-2 infection testing
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Germany4 sites
Diakonissenkrankenhaus Flensburg
Flensburg, 24939
PHV-Dialysezentrum Goslar
Goslar, 38642
Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen
Hanover, 30625
PHV Dialysezentrum Kiel
Kiel, 24106
Czechia2 sites
Fresenius Nephrocare Nymburk
Nymburk, 288 02
Fresenius Nephrocare Praha 9 - Vysocany
Prague, 190 61
Hungary2 sites
Péterfy II. Dialízis Központ
Budapest, 1077
Váci Dialízis Központ
Vác, 2600
About this study
Official title: Comparison of Clinical Performance and Hemocompatibility of Dialyzers Applied During Post-dilution Online Hemodiafiltration - eMPORA III Study (Modified POlysulfone membRAne)
Comparison of the clinical performance and the hemocompatibility profile of different high-flux dialyzers, all applied during post-dilution online hemodiafiltration
Read the detailed description
The primary objective of this study is to test whether the hemodialyzer FX CorAL 600 (applied during post-dilution online hemodiafiltration) is non-inferior or superior to the comparator hemodialyzers FX CorDiax 600 and xevonta Hi 15 in removing ß2-microglobulin.
The secondary objectives of this study are:
- To compare the FX CorAL 600 dialyzer with the comparator hemodialyzers FX CorDiax 600 and xevonta Hi 15 regarding their efficacies in removing other uremic toxins.
- To compare the FX CorAL 600 dialyzer with the comparator hemodialyzers FX CorDiax 600 and xevonta Hi 15 regarding their hemocompatibility profiles.
- Conditions
- Renal Failure, End Stage Renal Disease
- Being tested
- Dialyser
- Keywords
- Hemodialysis, Hemodiafiltration, Renal replacement therapy, Dialyzer
- Medical subject headings
- Renal Insufficiency, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DialyserDevice
Three consecutive treatment periods of four weeks, one last study week where the patient is re-assigned to the same type of dialyzer used before beginning the study and one follow-up week per patient. Each treatment period includes 12 hemodiafiltration HDF sessions and is assigned to one type of dialyzer: FX CorAL 600 Fresenius Medical Care, comparator FX CorDiax 600 Fresenius Medical Care and comparator xevonta Hi 15 (B. Braun).
| Study group | Role | What they receive |
|---|---|---|
| Hemodiafiltration HDF | Other | Three consecutive treatment periods of four weeks, one last study week where the patient is re-assigned to the same type of dialyzer used before beginning the study and one follow-up week per patient. Each treatment period includes 12 hemodiafiltration HDF sessions and is assigned to one type of dialyzer: FX CorAL 600 Fresenius Medical Care, comparator FX CorDiax 600 Fresenius Medical Care and comparator xevonta Hi 15 (B. Braun). Receives: Device: Dialyser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Removal rate of β2-microglobulin
Removal rate of β2-microglobulin will be calculated a primary endpoint in blood samples to evaluate the clinical Performance of the dialyzer FXCorAL
Measured: t=240 minutes of HDF
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start3 Feb 2021
- Primary completion5 May 2023
- Study completion5 May 2023
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 Renal 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Prospective, open, controlled, cross-over (with randomized treatment sequences), interventional, multi-center
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care Deutschland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut Dr. Schauerte GmbH (IDS)
- Responsible party
- Sponsor
- Investigators
- Götz Ehlerding, Dr med, Principal investigator, Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714281
- Sponsor's protocol ID
- HD-FX-08-EU
- Other IDs
- CIV-20-10-035024
- Acronym
- eMPORAIII
- Status last verified
- Sep 2024
- First submitted
- 14 Jan 2021
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ehlerding G, Ries W, Kempkes-Koch M, Ziegler E, Ronova P, Krizsan M, Veresova J, Boke M, Erlenkotter A, Nitschel R, Zawada AM, Kennedy JP, Braun J, Larkin JW, Korolev N, Lang T, Ottillinger B, Stauss-Grabo M, Griesshaber B. Randomized investigation of increased dialyzer membrane hydrophilicity on hemocompatibility and performance. BMC Nephrol. 2024 Jul 10;25(1):220. doi: 10.1186/s12882-024-03644-5.
PubMed 38987671
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Performance and Hemocompatibility of Dialyzers Applied During Post-dilution Online Hemodiafiltration - eMPORA III Study (Modified POlysulfone membRAne)
- ClinicalTrials.gov ID
- NCT04714281
- Acronym / sponsor ID
- eMPORAIII / HD-FX-08-EU
- Conditions
- Renal Failure, End Stage Renal Disease
- Keywords
- Hemodialysis, Hemodiafiltration, Renal replacement therapy, Dialyzer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Fresenius Medical Care Deutschland GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Institut Dr. Schauerte GmbH (IDS)
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 5 May 2023 (actual)
- First posted
- 19 Jan 2021 (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.
Comparison of the clinical performance and the hemocompatibility profile of different high-flux dialyzers, all applied during post-dilution online hemodiafiltration
Detailed description
The primary objective of this study is to test whether the hemodialyzer FX CorAL 600 (applied during post-dilution online hemodiafiltration) is non-inferior or superior to the comparator hemodialyzers FX CorDiax 600 and xevonta Hi 15 in removing ß2-microglobulin.
The secondary objectives of this study are:
- To compare the FX CorAL 600 dialyzer with the comparator hemodialyzers FX CorDiax 600 and xevonta Hi 15 regarding their efficacies in removing other uremic toxins.
- To compare the FX CorAL 600 dialyzer with the comparator hemodialyzers FX CorDiax 600 and xevonta Hi 15 regarding their hemocompatibility profiles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, open, controlled, cross-over (with randomized treatment sequences), interventional, multi-center
| Arm | Type | Receives |
|---|---|---|
| Hemodiafiltration HDF | Other | Device: DialyserThree consecutive treatment periods of four weeks, one last study week where the patient is re-assigned to the same type of dialyzer used before beginning the study and one follow-up week per patient. Each treatment period includes 12 hemodiafiltration HDF sessions and is assigned to one type of dialyzer: FX CorAL 600 Fresenius Medical Care, comparator FX CorDiax 600 Fresenius Medical Care and comparator xevonta Hi 15 (B. Braun). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Minimum age of 18 years
- Existing informed consent form signed and dated by study patient as well as investigator/authorized physician
- The patient is legally competent and able to understand the nature, risks, meaning, and consequences of the clinical trial and can subsequently declare her/his consent for participation in the clinical trial (cf. European Medical Device Directive and corresponding national regulations)
- Patients with a chronic kidney disease stage 5D (end stage renal disease with a glomerular filtration rate of 15 ml/min or less) on hemodiafiltration as extracorporeal renal replacement therapy
- On online post-dilution hemodiafiltration (HDF), at least 4 h treatment time thrice weekly with FX or FX CorDiax dialyzer ≥ 1 month
Key exclusion criteria (19 listed)
- Any condition which could interfere with the patient's ability to comply with the study. This decision is at the discretion of the treating physician and relates to the general stable condition of the patient (e.g. any acute condition, e.g. infection or mental problem which might give reason for concern etc.)
- Ongoing participation in an interventional clinical study during the preceding 30 days
- Previous participation in this study
- Pregnancy (pregnancy test will be conducted at start and end of study with female patients aged < 55 years) or lactation period
- Patient is not able to give informed consent according to the European Medical Device Directive and corresponding national regulations
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 |
|---|---|---|
| DialyserThree consecutive treatment periods of four weeks, one last study week where the patient is re-assigned to the same type of dialyzer used before beginning the study and one follow-up week per patient. Each treatment period includes 12 hemodiafiltration HDF sessions and is assigned to one type of dialyzer: FX CorAL 600 Fresenius Medical Care, comparator FX CorDiax 600 Fresenius Medical Care and comparator xevonta Hi 15 (B. Braun). | Device | Hemodiafiltration HDF |
Primary outcome
Removal rate of β2-microglobulin
Time frame: t=240 minutes of HDF
Removal rate of β2-microglobulin will be calculated a primary endpoint in blood samples to evaluate the clinical Performance of the dialyzer FXCorAL
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 27 Sep 2024.
- Results publication: PubMed 38987671Ehlerding G, Ries W, Kempkes-Koch M, Ziegler E, Ronova P, Krizsan M, Veresova J, Boke M, Erlenkotter A, Nitschel R, Zawada AM, Kennedy JP, Braun J, Larkin JW, Korolev N, Lang T, Ottillinger B, Stauss-Grabo M, Griesshaber B. Randomized investigation of increased dialyzer membrane hydrophilicity on hemocompatibility and performance. BMC Nephrol. 2024 Jul 10;25(1):220. doi: 10.1186/s12882-024-03644-5.
- Link to PubMed ID 38987671Link provided by the sponsor.
- 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.
Götz Ehlerding, Dr med principal investigator
Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialyser in people with Renal Failure and End Stage Renal Disease, run by Fresenius Medical Care Deutschland GmbH at 8 sites in 3 countries.
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 8 inclusion and 19 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 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Czechia, Hungary. 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?
Removal rate of β2-microglobulin (time frame: t=240 minutes of HDF). 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 NCT04714281, 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 27 Sep 2024.