Renal FailurecomPERFORMStudNCT04102280
Comparative Clinical Performance of Dialyzers Applied During High Volume Online Haemodiafiltration
A study testing Dialyser in people with Renal Failure and End Stage Renal Disease, run by Fresenius Medical Care Deutschland GmbH at 4 sites in Germany.
Trial summary
The clinical investigation will be performed to generate clinical data on clearances and removal rates for ß2-microglobulin and other uremic toxins and on clinical adverse events of the modified polysulfone membrane to fulfil obligations to follow the FX P600 dialyzer in the market. 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
- 52 participants
- Where
- 4 sitesGermany
- Study dates
- 29 Oct 2019to 26 May 2021
- 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:
- Informed consent signed and dated by study patient and investigator/authorized physician
- Minimum age of 18 years
- Legally competent and able to understand the nature, risk, meaning, and consequences of the clinical trial (cf. MPG § 20 Sec. 2 Sentence 1 No. 1)
- Chronic kidney disease stage 5D (end stage renal disease) on hemodiafiltration as extracorporeal renal replacement therapy
- Study-specific:
- On high volume online (>21 L/session substitution volume postdilution per session) hemodiafiltration (HDF), at least 4 h treatment time thrice weekly ≥3 month
- Vascular access (fistula or graft) and high flow double lumen catheter which enables suitable effective 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 or lactation period
- Patient is not able to give informed consent according to MPG § 20 Sec. 2 Sentence 1 No. 1
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- 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)
- Single needle treatments
- Catheter as vascular access (except high flow double lumen catheter)
- Unstable patients (due to e.g. acute intercurrent disease like myocardial infarction, cerebrovascular accident, peripheral arterial occlusion, active malignant disease, use of antibiotics within the last 4 weeks)
- Patients with heart failure (NYHA ≥ 3), COPD (GOLD 2-4), frequent intradialytic symptomatic hypotension requiring intervention within the last 2 months prior to study start (>3 times, respectively)
- Patients with known or suspected allergy to trial product and related products
- Patients with chronic antiallergic medication due to immune-mediated disease
- Planned absence from dialysis unit within the 4 weeks of study duration e.g. due to scheduled hospitalization, holidays or any other reason
- Active HBV, HCV, HIV infection
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Diakonissenkrankenhaus Flensburg
Flensburg, 24939
PHV-Dialysezentrum Goslar
Goslar, 38642
Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen
Hanover, 30625
PHV Dialysezentrum Kiel
Kiel, 24106
About this study
Official title: Comparative Clinical Performance of Dialyzers Applied During High Volume Online Haemodiafiltration - comPERFORM Study (Comparative PERFORMance)
The clinical investigation will be performed to generate clinical data on clearances and removal rates for ß2-microglobulin and other uremic toxins and on clinical adverse events of the modified polysulfone membrane to fulfil obligations to follow the FX P600 dialyzer in the market.
Read the detailed description
The primary objective of this study is to test whether the FX P600 is non-inferior to the Xevonta Hi 15 dialyzer and the Elisio 150H dialyzer in removing β2-microglobulin related to the albumin removal into the dialysate during high volume online hemodiafiltration.
The secondary objective of this study is to compare the FX P600 dialyzer with the comparator dialyzers with regard to their efficacies in removing other performance variables (see below). Furthermore, the safety of the FX P600 will be investigated by collecting and analyzing clinical adverse events.
- Conditions
- Renal Failure, End Stage Renal Disease
- Being tested
- Dialyser
- 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.
DialyserDevice
Three consecutive treatment weeks and one follow-up week per patient. Each treatment week includes three hemodiafiltration HDF sessions and is assigned to one type of dialyzer: FX P600 Fresenius Medical Care, comparator Xevonta Hi 15 (B. Braun) and comparator Elisio 150H (Nipro)
| Study group | Role | What they receive |
|---|---|---|
| Hemodiafiltration HDF | Other | Three consecutive treatment weeks and one follow-up week per patient. Each treatment week includes three hemodiafiltration HDF sessions and is assigned to one type of dialyzer: FX P600 Fresenius Medical Care, comparator Xevonta Hi 15 (B. Braun) and comparator Elisio 150H (Nipro) 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 in Plasma related to the albumin removal into the dialysate
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 posted25 Sep 2019
- Study start29 Oct 2019
- Primary completion6 Nov 2020
- Study completion26 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care Deutschland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut Dr. Schauerte (IDS)
- Responsible party
- Sponsor
- Investigators
- Götz Ehlerding, Dr med, Principal investigator, Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04102280
- Sponsor's protocol ID
- HD-FX-07-D
- Acronym
- comPERFORMStud
- Status last verified
- Nov 2021
- First submitted
- 23 Sep 2019
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical Performance of Dialyzers Applied During High Volume Online Haemodiafiltration - comPERFORM Study (Comparative PERFORMance)
- ClinicalTrials.gov ID
- NCT04102280
- Acronym / sponsor ID
- comPERFORMStud / HD-FX-07-D
- Conditions
- Renal Failure, End Stage Renal Disease
- Keywords
- Hemodialysis, Hemodiafiltration, Renal replacement therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Fresenius Medical Care Deutschland GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Institut Dr. Schauerte (IDS)
- Study start
- 29 Oct 2019 (actual)
- Primary completion
- 6 Nov 2020 (actual)
- Study completion
- 26 May 2021 (actual)
- First posted
- 25 Sep 2019 (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 generate clinical data on clearances and removal rates for ß2-microglobulin and other uremic toxins and on clinical adverse events of the modified polysulfone membrane to fulfil obligations to follow the FX P600 dialyzer in the market.
Detailed description
The primary objective of this study is to test whether the FX P600 is non-inferior to the Xevonta Hi 15 dialyzer and the Elisio 150H dialyzer in removing β2-microglobulin related to the albumin removal into the dialysate during high volume online hemodiafiltration.
The secondary objective of this study is to compare the FX P600 dialyzer with the comparator dialyzers with regard to their efficacies in removing other performance variables (see below). Furthermore, the safety of the FX P600 will be investigated by collecting and analyzing clinical adverse events.
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 weeks and one follow-up week per patient. Each treatment week includes three hemodiafiltration HDF sessions and is assigned to one type of dialyzer: FX P600 Fresenius Medical Care, comparator Xevonta Hi 15 (B. Braun) and comparator Elisio 150H (Nipro) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Informed consent signed and dated by study patient and investigator/authorized physician
- Minimum age of 18 years
- Legally competent and able to understand the nature, risk, meaning, and consequences of the clinical trial (cf. MPG § 20 Sec. 2 Sentence 1 No. 1)
- Chronic kidney disease stage 5D (end stage renal disease) on hemodiafiltration as extracorporeal renal replacement therapy
- On high volume online (>21 L/session substitution volume postdilution per session) hemodiafiltration (HDF), at least 4 h treatment time thrice weekly ≥3 month
Key exclusion criteria (16 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 or lactation period
- Patient is not able to give informed consent according to MPG § 20 Sec. 2 Sentence 1 No. 1
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 weeks and one follow-up week per patient. Each treatment week includes three hemodiafiltration HDF sessions and is assigned to one type of dialyzer: FX P600 Fresenius Medical Care, comparator Xevonta Hi 15 (B. Braun) and comparator Elisio 150H (Nipro) | Device | Hemodiafiltration HDF |
Primary outcome
Removal rate of β2-microglobulin
Time frame: t=240 minutes of HDF
Removal rate of β2-microglobulin in Plasma related to the albumin removal into the dialysate
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 2 Dec 2021.
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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
4 sites in 1 country: 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 4 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 8 inclusion and 16 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 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
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 2 Dec 2021.