End-stage Renal DiseaseNCT04395131
Clearum High Flux Hemodialyzer Used in Hemodialysis for Subjects With End-Stage Renal Disease
A study testing Clearum HF Hemodialyzer in people with End-stage Renal Disease, run by Mozarc Medical US LLC at 1 site in Germany.
Trial summary
The study will be a prospective, interventional, non-randomized, single-center study in 20 ESRD patients on hemodialysis. The study will compare performance of the Clearum HS dialyzer to typical values obtained with other commercially available high flux dialyzers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Renal Disease
- What is being tested?
- Clearum HF Hemodialyzer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 3 Apr 2020to 14 Aug 2020
- 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
- ESRD Patients aged 18 years or older
- Patients able to give informed consent (IC) and interested to participate in the study
- Stable (according to the investigator) on hemodialysis for more than 3 months with previous treatments of 3x weekly hemodialysis or hemodiafiltration
- Stable hemoglobin between 10 and 12 g/dl in the most recent two consecutive blood draws
- Stable anticoagulation and ESA regimen with no dosing modifications in the past 1 month
- Patients who have an adequate AVF or graft, capable of providing a blood flow rate of at least 300 mL/min according to sessions conducted in past month
Who cannot join
- Patients who have acute renal failure with the chance for recovery.
- Patients who are pre-scheduled for a living kidney transplant within the next two months, who plan a change to PD within the next two months or who require single needle dialysis therapy.
- Pregnant and lactating women.
- Patients with a history of positive serology tests for Hepatitis B surface antigen, positive Hepatitis C total antibody, HIV and syphilis.
- Patients with known hemodynamic instability, anemia (Hgb < 90 g/L), and/or severe bleeding risks secondary to coagulation disorders.
- Patients with active or ongoing infection per investigator's judgement.
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- Patients with a history of solid tumors requiring anti-cancer therapy in the past or next 6 months or a life expectancy less than 1 year or patients with a history of a hematology neoplasm.
- Patients diagnosed with a NYHA Class IV congestive heart failure, or acute coronary syndrome and/or who have suffered a myocardial infarction within three months prior to the start of the study.
- Patients with a history of severe mental disorders.
- Patients who are currently participating or have previously participated in another interventional clinical trial in the past 4 weeks.
- Patients who have had an allergic response to polyarylethersulfone (PAES) or polysulfone membranes or have a history of poor tolerance to dialyzers with synthetic membranes.
- Patients with advanced liver, heart or pulmonary disease as judged by the Investigator
- Patients with any comorbidity possibly conflicting with the study purpose or procedures as judged by the Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clearum High Flux Hemodialyzer: Safety and Performance Clinical Study
The study will be a prospective, interventional, non-randomized, single-center study in 20 ESRD patients on hemodialysis. The study will compare performance of the Clearum HS dialyzer to typical values obtained with other commercially available high flux dialyzers. In addition, the Clearum HS dialyzer will be compared to a Fresenius FX80 dialyzer for a baseline (control) comparison. This will be a post-market study. The duration of the trial is 2 weeks for the FX80 control dialyzer + 6 weeks with the Clearum HS dialyzer used for 3x weekly high flux hemodialysis.
Read the detailed description
The study will compare performance to typical values obtained with commercially available dialyzers used for high flux hemodialysis and comparing the Clearum HS dialyzer to the baseline values of a control FX80 Dialyzer.
The duration of the trial is 2 weeks for the FX80 control dialyzer + 6 weeks with the Clearum HS dialyzer used for 3x weekly high flux hemodialysis.
The sampling, reported in Table 1 below, will be done at mid-week sessions (pre and post session sampling) and consists of a blood draw for baseline dialysis with the FX80 weeks 1 and 2, or Clearum HS dialyzer at weeks 3, 5 and 8 for uremic toxins: urea, creatinine, phosphate, B2-microglobulin, albumin, sodium, potassium, calcium, magnesium, platelets and leucocytes, and platelets. In addition, a presession sample will be taken for coagulation parameter TAT, hematocrit and inflammatory markers IL6 and C reactive protein at baseline for FX80 at mid-week sessions during weeks 1 and 2 and during weeks 3, 5 and 8 for the Clearum HS dialyzer.
Instantaneous B2M clearance sampling will be done at week 7 during the Clearum HS dialyzer phase and consists of a blood sample prior to the dialyzer and immediately after the dialyzer at two time points, 15-30 min and at 120-150 min, respectively.
Blood rest will be done by comparing the dialyzer to a set of 5 illustrations and giving a score of 1 (worst) to 5 (best) that best correlates the dialyzer with the illustration, at the end of the dialysis session after blood has been returned to the patients (both FX80 and Clearum HS) on the sampling days.
The patients will be treated for 2 weeks with a standard dialyzer (FX80) and an additional 6 weeks with the Clearum HS dialyzer (experimental period). Both hemodialyzers will be used for 3 times a week. Expected duration for the study including enrolment will be 3 months.
The study duration will be approximately 3-4 months. Each patient will receive 6 hemodialysis sessions with FX80 and 18 sessions with Clearum HS hemodialyzer, and the treatment time will be between 3.5 and 4.5 hours
- Conditions
- End-stage Renal Disease
- Being tested
- Clearum HF Hemodialyzer
- 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.
Clearum HF HemodialyzerDevice
the hemodialyzer will be used 3x week for 3.5-4.5 hours with a Qb of at least 350 ml/min
| Study group | Role | What they receive |
|---|---|---|
| Clearum HF Dialysis Subjects | Other | All subjects enrolled in the study and treated with the Clearum HF hemodialyzer Receives: Device: Clearum HF Hemodialyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate performance of small-solute (toxin) removal
The primary objective of this study is to evaluate performance of small-solute (toxin) removal, represented by urea, under standard high flux hemodialysis conditions with a mean urea reduction ratio (URR) of 65% or greater.
Measured: End of dialysis treatment
Secondary outcomes (8)
Adverse Events
Evaluate of all adverse events during the study period
Measured: 8 weeks, 3 sessions per week
B2M reduction ratio
Evaluate performance of the B2M reduction ratio
Measured: 5 sampling at mid-week session of week 1, 2, 3, 5 and 8
Instantaneous clearance of B2M during specified time-points
Evaluate the instantaneous clearance of B2M for the Clearum HS dialyzer at 15-30 min and at 120-150 min at session the mid-week session of week 2 with the Clearum dialyzer.
Measured: 1 sampling at mid-week session of week 7
Reduction ratio of albumin during hemodialysis
Evaluate the reduction ratio of albumin during the hemodialysis session with the Clearum dialyzer and any trends in albumin concentration over a 6-week period
Measured: 5 sampling at mid-week session of week 1, 2, 3, 5 and 8
Follow-up of CRP for patients treated with Clearum dialyzer
Observe the trends in inflammatory markers CRP over a 6-week period
Measured: Kinetic over 6 week period
Follow-up of IL6 for patients treated with Clearum dialyzer
Observe the trends in inflammatory markers IL6 over a 6-week period
Measured: Kinetic over 6 week period
Evaluation of TAT (Thrombin-antithrombin) complex
Evaluate coagulation parameters as assessed by Thrombin-anti-thrombin (TAT) on the dialyzer after blood restitution at the end of the dialytic session for sessions where sampling occurs
Measured: End of dialysis treatment
Quality of rinse-back (filter and circuit) via a visual scale
Evaluate on a qualitative photo visual score ranging from poor to very good (1-5) for the residual blood remaining in the dialyzer after rinse back at the end of the session
Measured: End of dialysis treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start3 Apr 2020
- Primary completion14 Aug 2020
- Study completion14 Aug 2020
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.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mozarc Medical US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04395131
- Sponsor's protocol ID
- SA0720191
- Status last verified
- Mar 2026
- First submitted
- 30 Apr 2020
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- 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 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clearum High Flux Hemodialyzer: Safety and Performance Clinical Study
- ClinicalTrials.gov ID
- NCT04395131
- Acronym / sponsor ID
- SA0720191
- Conditions
- End-stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mozarc Medical US LLCIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2020 (actual)
- Primary completion
- 14 Aug 2020 (actual)
- Study completion
- 14 Aug 2020 (actual)
- First posted
- 20 May 2020 (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 study will be a prospective, interventional, non-randomized, single-center study in 20 ESRD patients on hemodialysis. The study will compare performance of the Clearum HS dialyzer to typical values obtained with other commercially available high flux dialyzers. In addition, the Clearum HS dialyzer will be compared to a Fresenius FX80 dialyzer for a baseline (control) comparison. This will be a post-market study. The duration of the trial is 2 weeks for the FX80 control dialyzer + 6 weeks with the Clearum HS dialyzer used for 3x weekly high flux hemodialysis.
Detailed description
The study will compare performance to typical values obtained with commercially available dialyzers used for high flux hemodialysis and comparing the Clearum HS dialyzer to the baseline values of a control FX80 Dialyzer.
The duration of the trial is 2 weeks for the FX80 control dialyzer + 6 weeks with the Clearum HS dialyzer used for 3x weekly high flux hemodialysis.
The sampling, reported in Table 1 below, will be done at mid-week sessions (pre and post session sampling) and consists of a blood draw for baseline dialysis with the FX80 weeks 1 and 2, or Clearum HS dialyzer at weeks 3, 5 and 8 for uremic toxins: urea, creatinine, phosphate, B2-microglobulin, albumin, sodium, potassium, calcium, magnesium, platelets and leucocytes, and platelets. In addition, a presession sample will be taken for coagulation parameter TAT, hematocrit and inflammatory markers IL6 and C reactive protein at baseline for FX80 at mid-week sessions during weeks 1 and 2 and during weeks 3, 5 and 8 for the Clearum HS dialyzer.
Instantaneous B2M clearance sampling will be done at week 7 during the Clearum HS dialyzer phase and consists of a blood sample prior to the dialyzer and immediately after the dialyzer at two time points, 15-30 min and at 120-150 min, respectively.
Blood rest will be done by comparing the dialyzer to a set of 5 illustrations and giving a score of 1 (worst) to 5 (best) that best correlates the dialyzer with the illustration, at the end of the dialysis session after blood has been returned to the patients (both FX80 and Clearum HS) on the sampling days.
The patients will be treated for 2 weeks with a standard dialyzer (FX80) and an additional 6 weeks with the Clearum HS dialyzer (experimental period). Both hemodialyzers will be used for 3 times a week. Expected duration for the study including enrolment will be 3 months.
The study duration will be approximately 3-4 months. Each patient will receive 6 hemodialysis sessions with FX80 and 18 sessions with Clearum HS hemodialyzer, and the treatment time will be between 3.5 and 4.5 hours
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clearum HF Dialysis Subjects | Other | Device: Clearum HF HemodialyzerAll subjects enrolled in the study and treated with the Clearum HF hemodialyzer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ESRD Patients aged 18 years or older
- Patients able to give informed consent (IC) and interested to participate in the study
- Stable (according to the investigator) on hemodialysis for more than 3 months with previous treatments of 3x weekly hemodialysis or hemodiafiltration
- Stable hemoglobin between 10 and 12 g/dl in the most recent two consecutive blood draws
- Stable anticoagulation and ESA regimen with no dosing modifications in the past 1 month
Key exclusion criteria (13 listed)
- Patients who have acute renal failure with the chance for recovery.
- Patients who are pre-scheduled for a living kidney transplant within the next two months, who plan a change to PD within the next two months or who require single needle dialysis therapy.
- Pregnant and lactating women.
- Patients with a history of positive serology tests for Hepatitis B surface antigen, positive Hepatitis C total antibody, HIV and syphilis.
- Patients with known hemodynamic instability, anemia (Hgb < 90 g/L), and/or severe bleeding risks secondary to coagulation disorders.
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 |
|---|---|---|
| Clearum HF Hemodialyzerthe hemodialyzer will be used 3x week for 3.5-4.5 hours with a Qb of at least 350 ml/min | Device | Clearum HF Dialysis Subjects |
Primary outcome
Evaluate performance of small-solute (toxin) removal
Time frame: End of dialysis treatment
The primary objective of this study is to evaluate performance of small-solute (toxin) removal, represented by urea, under standard high flux hemodialysis conditions with a mean urea reduction ratio (URR) of 65% or greater.
8 secondary outcomes
Adverse Events
Time frame: 8 weeks, 3 sessions per week
B2M reduction ratio
Time frame: 5 sampling at mid-week session of week 1, 2, 3, 5 and 8
Instantaneous clearance of B2M during specified time-points
Time frame: 1 sampling at mid-week session of week 7
Reduction ratio of albumin during hemodialysis
Time frame: 5 sampling at mid-week session of week 1, 2, 3, 5 and 8
Follow-up of CRP for patients treated with Clearum dialyzer
Time frame: Kinetic over 6 week period
Follow-up of IL6 for patients treated with Clearum dialyzer
Time frame: Kinetic over 6 week period
Evaluation of TAT (Thrombin-antithrombin) complex
Time frame: End of dialysis treatment
Quality of rinse-back (filter and circuit) via a visual scale
Time frame: End of dialysis treatment
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 1 Apr 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clearum HF Hemodialyzer in people with End-stage Renal Disease, run by Mozarc Medical US LLC at 1 site 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 6 inclusion and 13 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 1 Apr 2026. 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 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?
Evaluate performance of small-solute (toxin) removal (time frame: End of dialysis treatment). 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 1 Apr 2026.