Renal FailureeMPORA IINCT03611218
Comparative Safety and Clinical Performance of Dialyzers Applied During Post-dilution Online Hemodiafiltration
A study testing Dialyzer in people with Renal Failure and End Stage Renal Disease, run by Fresenius Medical Care Deutschland GmbH at 6 sites in Germany.
Trial summary
The clinical Investigation will be performed to compare the safety and clinical performance profile of different hemodialyzers, all applied in on-line postdilution 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?
- Dialyzer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 6 sitesGermany
- Study dates
- 29 Aug 2018to 8 Dec 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
- 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 his consent for participation in the clinical trial
- 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
Who cannot join
- 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. absence of 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 with female patients aged ≤ 55 years) or lactation period
- Patient is not able to give informed consent
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Diakonissenkrankenhaus Flensburg
Flensburg, 24939
Georg-Haas-Dialysezentrum der PHV
Giessen, 35392
PHV-Dialysezentrum Goslar
Goslar, 38642
Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen
Hanover, Lower Saxony, 30453
PHV Dialysezentrum Kiel
Kiel, 24106
PHV-Dialysezentrum Lauterbach
Lauterbach, 36341
About this study
Official title: Comparative Safety and Clinical Performance of Dialyzers Applied During Post-dilution Online Hemodiafiltration - eMPORA II Study (Modified POlysulfone membRAne)
The clinical Investigation will be performed to compare the safety and clinical performance profile of different hemodialyzers, all applied in on-line postdilution hemodiafiltration
Read the detailed description
The primary objective of this study is to test whether the new FX P600 (applied during post-dilution online HDF) is non-inferior to two comparator dialyzers (Sureflux-17UX (Nipro) and Polyflux 170 H (Baxter/Gambro) in removing β2-microglobulin. The secondary objective is to exploratively compare the efficacy in removing other uremic solutes between the new FX P600 and the Sureflux-17UX as well as the Polyflux 170 H membranes. Additionally, the safety of the FX P600 dialyzer with a modified polysulfone membrane will be investigated.
- Conditions
- Renal Failure, End Stage Renal Disease
- Being tested
- Dialyzer
- Keywords
- Hemodialysis, Hemodiafiltration, Renal replacement therapy
- 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.
DialyzerDevice
Three hemodiafiltration sessions assigned to one type of dialyzer FX P600 (Fresenius Medical Care), comparator Sureflux-17UX and comparator Polyflux 170 H
| Study group | Role | What they receive |
|---|---|---|
| Hemodiafiltration HDF | Other | Three consecutive treatment weeks and on follow-up week per patient. Each treatment week includes three hemodiafiltration HDFsessions and is assigned to one type of dialyzer: FX P600 Fresenius Medical Care, comparator Nipro: Sureflux-17UX and comparator Baxter/Gambro: Polyflux 170 H. Receives: Device: Dialyzer |
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 as primary endpoint in blood samples to evaluate the clinical performance of the new FX P600 dialyzer.
Measured: t=240 minutes of HDF
Secondary outcomes (3)
Clearance of β2-microglobulin
Measured: t=60 minutes of HDF
Removal rate of α1-microglobulin
Measured: t=240 minutes of HDF
Clearance of α1-microglobulin
Measured: t= 60 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 posted2 Aug 2018
- Study start29 Aug 2018
- Primary completion8 Dec 2018
- Study completion8 Dec 2018
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
- Intervention model
- Sequential
- Model description
- Prospective, open, controlled, cross-over (with randomized treatment sequences), interventional, multi-center
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care Deutschland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611218
- Sponsor's protocol ID
- HD-FX-06-D
- Acronym
- eMPORA II
- Status last verified
- Dec 2018
- First submitted
- 27 Jul 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ehlerding G, Erlenkotter A, Gauly A, Griesshaber B, Kennedy J, Rauber L, Ries W, Schmidt-Gurtler H, Stauss-Grabo M, Wagner S, Zawada AM, Zschatzsch S, Kempkes-Koch M. Performance and Hemocompatibility of a Novel Polysulfone Dialyzer: A Randomized Controlled Trial. Kidney360. 2021 Apr 7;2(6):937-947. doi: 10.34067/KID.0000302021. eCollection 2021 Jun 24.
PubMed 35373083
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Safety and Clinical Performance of Dialyzers Applied During Post-dilution Online Hemodiafiltration - eMPORA II Study (Modified POlysulfone membRAne)
- ClinicalTrials.gov ID
- NCT03611218
- Acronym / sponsor ID
- eMPORA II / HD-FX-06-D
- Conditions
- Renal Failure, End Stage Renal Disease
- Keywords
- Hemodialysis, Hemodiafiltration, Renal replacement therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Fresenius Medical Care Deutschland GmbHIndustry (pharma, biotech, devices)
- Study start
- 29 Aug 2018 (actual)
- Primary completion
- 8 Dec 2018 (actual)
- Study completion
- 8 Dec 2018 (actual)
- First posted
- 2 Aug 2018 (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 clinical Investigation will be performed to compare the safety and clinical performance profile of different hemodialyzers, all applied in on-line postdilution hemodiafiltration
Detailed description
The primary objective of this study is to test whether the new FX P600 (applied during post-dilution online HDF) is non-inferior to two comparator dialyzers (Sureflux-17UX (Nipro) and Polyflux 170 H (Baxter/Gambro) in removing β2-microglobulin. The secondary objective is to exploratively compare the efficacy in removing other uremic solutes between the new FX P600 and the Sureflux-17UX as well as the Polyflux 170 H membranes. Additionally, the safety of the FX P600 dialyzer with a modified polysulfone membrane will be investigated.
Study design
- Primary purpose
- Treatment
- 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: DialyzerThree consecutive treatment weeks and on follow-up week per patient. Each treatment week includes three hemodiafiltration HDFsessions and is assigned to one type of dialyzer: FX P600 Fresenius Medical Care, comparator Nipro: Sureflux-17UX and comparator Baxter/Gambro: Polyflux 170 H. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 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 his consent for participation in the clinical trial
- 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
Key exclusion criteria (5 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. absence of 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 with female patients aged ≤ 55 years) or lactation period
- Patient is not able to give informed consent
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 |
|---|---|---|
| DialyzerThree hemodiafiltration sessions assigned to one type of dialyzer FX P600 (Fresenius Medical Care), comparator Sureflux-17UX and comparator Polyflux 170 H | 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 as primary endpoint in blood samples to evaluate the clinical performance of the new FX P600 dialyzer.
3 secondary outcomes
Clearance of β2-microglobulin
Time frame: t=60 minutes of HDF
Removal rate of α1-microglobulin
Time frame: t=240 minutes of HDF
Clearance of α1-microglobulin
Time frame: t= 60 minutes of HDF
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 19 Dec 2018.
- Derived from this study: PubMed 35373083Ehlerding G, Erlenkotter A, Gauly A, Griesshaber B, Kennedy J, Rauber L, Ries W, Schmidt-Gurtler H, Stauss-Grabo M, Wagner S, Zawada AM, Zschatzsch S, Kempkes-Koch M. Performance and Hemocompatibility of a Novel Polysulfone Dialyzer: A Randomized Controlled Trial. Kidney360. 2021 Apr 7;2(6):937-947. doi: 10.34067/KID.0000302021. eCollection 2021 Jun 24.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialyzer in people with Renal Failure and End Stage Renal Disease, run by Fresenius Medical Care Deutschland GmbH at 6 sites in Germany.
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 5 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 19 Dec 2018. 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 Germany. 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 NCT03611218, 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 19 Dec 2018.