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End Stage Renal DiseaseNCT03499691

Exploratory Study to Explore the Safety and Efficacy of the HDx Therapy Using Theranova 500 Dialyzer in Comparison to Hemodiafiltration

A study testing Theranova 500 medium cut-off dialyzer and Hemodiafiltration in people with End Stage Renal Disease, run by Vantive Health LLC at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Today it is well established that middle molecules comprise several compounds that are not effectively removed by high-flux dialyzers, and effective clearance of large middle molecules in the process of dialysis depends on the dialyzer membrane having large enough pore sizes, larger than the conventional high-flux… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
End Stage Renal Disease
What is being tested?
Theranova 500 medium cut-off dialyzer and Hemodiafiltration
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteSpain
Study dates
11 Apr 2018to 4 Oct 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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ESRD patients age between 18 - 80 years
  • Clinically stable as judged by the treating physician for 30 days prior to enrollment, as demonstrated by pertinent patient medical history, physical examination, and laboratory testing
  • Hemodialysis therapy with HDF for at least 3 months immediately prior to study enrollment

Who cannot join

  • No informed consent provided
  • Significant psychiatric disorder, mental disability, or other condition that may interfere with the patient's ability to provide informed consent
  • Pregnant, breastfeeding, or planning to become pregnant
  • Unstable vascular access associated with risk of low and variable extracorporeal blood flow rate (QB)
  • Chronic liver disease, known paraprotein-associated disease, known bleeding disorders (e.g., gastrointestinal bleed, colonic polyps, small bowel angiodysplasia and active peptic ulcers)
  • Major bleeding episode (i.e. soft tissue bleeding, blood in stool, joint damage, retinal bleeding, extensive mucosal bleeding, exsanguination, cerebral hemorrhage) ≤ 12 weeks prior to enrollment
Show all 13Show fewer
  • Blood (red blood cell) transfusion ≤ 12 weeks prior to enrollment
  • Clinical signs of acute infection ≤ 4 weeks prior to enrollment
  • Active cancer, except for basal cell or squamous cell skin cancer
  • Positive serology test for human immunodeficiency virus or hepatitis infection
  • Scheduled for planned interventions requiring hospitalization > 1 week
  • Scheduled for living-donor transplantation within the study period
  • Currently participating in another interventional clinical study or has participated in another interventional clinical study in the past 3 months that may interfere with this study

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • RTS Murcia VII, RTS Servicios de Diálisis S.L.U.

    Murcia

Other trials in Spain

About this study

Official title: An Open-label, Prospective, Randomized, Parallel-Group, Exploratory Study to Explore the Safety and Efficacy of the HDx Therapy Using Theranova 500 Dialyzer in Comparison to Hemodiafiltration

Today it is well established that middle molecules comprise several compounds that are not effectively removed by high-flux dialyzers, and effective clearance of large middle molecules in the process of dialysis depends on the dialyzer membrane having large enough pore sizes, larger than the conventional high-flux dialyzers. Studies have found associations between levels of large middle molecule uremic toxins and immune dysfunction and inflammation, as well as adverse outcomes. This indicates that dialysis membranes having larger pores, enabling an expanded HD (HDx) with more effective removal of large middle molecules, can have a positive impact on the inflammatory state. While data is starting to appear on the long-term use of the HDx therapy, little is still known on how large middle molecules and inflammation markers are affected over time.

Being tested
Theranova 500 medium cut-off dialyzer, Hemodiafiltration
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 medium cut-off dialyzerDevice

    The patients randomized in this group using the Theranova 500 medium cut-off dialyzer, and blood flow rate and treatment duration will be maintained stable during the observation period. However, other prescriptions will vary based on the Principal Investigator's (PI's) judgment. If other dialyzers need to be temporarily used during the study period it shall be recorded which alternative dialyzers are used and for how long the study patient is on a different dialyzer. However, prior to Week 12 laboratory assessment it is recommended that the patient undergoes three dialysis sessions on the designated treatment mode.

  • HemodiafiltrationDevice

    The patients randomized in this group using the on-line high-flux HDF dialyzer, in post dilution mode, will continue to receive treatments according to their current treatment prescriptions for the duration of the study.

Study groups in NCT03499691
Study groupRoleWhat they receive
Expanded Hemodialysis (HDx) TherapyExperimentalPatients will undergo 3 dialysis sessions per week with Theranova 500 for up to 24 weeks.
Receives: Device: Theranova 500 medium cut-off dialyzer
Hemodiafiltration (HDF) TherapyActive comparatorPatients will undergo 3 dialysis sessions per week with on-line HDF for up to 24 weeks.
Receives: Device: Hemodiafiltration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction ratios of lambda immunoglobulin free light chains (λ-FLC)

    Measured: Week 12

  2. Reduction ratios of kappa immunoglobulin free light chains (k-FLC)

    Measured: Week 12

  3. Reduction ratios of chitinase-3-like protein 1 (YKL-40)

    Measured: Week 12

  4. Reduction ratios of fibroblast growth factor 23 (FGF-23)

    Measured: Week 12

  5. Reduction ratios of serum beta-2 microglobulin (β2M)

    Measured: Week 12

Secondary outcomes (21)

  1. Change from baseline in mid-week pre-dialysis serum levels of λ-FLC, κ-FLC, YKL-40, FGF-23, ß2M

    Measured: Week 12 and 24

  2. Change from baseline in mid-week pre-dialysis serum levels of pentraxin-3 (PTX-3), high sensitivity C-reactive protein (hs-CRP), interleukin (IL-6), and interleukin-10 (IL-10)

    Measured: Week 12 and 24

  3. Percent change from pre- to post-dialysis in mid-week serum levels of hs-CRP

    Measured: Week 12

  4. Percent change from pre- to post-dialysis in mid-week serum levels of PTX-3

    Measured: Week 12

  5. Percent change from pre- to post-dialysis in mid-week serum levels of IL-6

    Measured: Week 12

  6. Percent change from pre- to post-dialysis in mid-week serum levels of IL-10

    Measured: Week 12

  7. Change from baseline in mid-week pre-dialysis serum level of fibrinogen

    Measured: Week 12 and 24

  8. Change from baseline in mid-week pre-dialysis serum level of albumin

    Measured: Week 12 and 24

  9. Single pool Kt/Vurea

    Measured: Week 24

  10. Serum phosphorous

    Measured: Week 24

  11. Kidney Disease Quality of Life 36 (KDQOL-36)

    Measured: Baseline, Week 12, Week 24

  12. Dialysis Symptom Index (DSI)

    Measured: Baseline, Week 12, Week 24

  13. Serum ferritin

    Measured: Baseline, Week 12, Week 24

  14. Transferrin Saturation (TSAT)

    Measured: Baseline, Week 12, Week 24

  15. 24-hour urine output on monthly basis

    Measured: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6

  16. Erythropoiesis stimulating agent (ESA) responsiveness

    Measured: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

  17. Hemoglobin levels

    Measured: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

  18. ESA dosage by type, administration frequency, and route

    Measured: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

  19. Intravenous iron dosage

    Measured: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

  20. Number of adverse events of hospitalization, cardiovascular events, and infective episodes

    Measured: Week 1 through Week 24

  21. Total patient death

    Measured: Week 1 through Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2018
  2. Study start11 Apr 2018
  3. Primary completion4 Oct 2018
  4. Study completion4 Oct 2018

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03499691
Sponsor's protocol ID
BXU012191
Status last verified
Mar 2025
First submitted
9 Apr 2018
Last updated
13 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hadad-Arrascue F, Nilsson LG, Rivera AS, Bernardo AA, Cabezuelo Romero JB. Expanded hemodialysis as effective alternative to on-line hemodiafiltration: A randomized mid-term clinical trial. Ther Apher Dial. 2022 Feb;26(1):37-44. doi: 10.1111/1744-9987.13700. Epub 2021 Jun 29.

    PubMed 34125503

Questions about this trial

What is this clinical trial studying?

A study testing Theranova 500 medium cut-off dialyzer and Hemodiafiltration in people with End Stage Renal Disease, run by Vantive Health LLC at 1 site in Spain.

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 3 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 13 Mar 2025. 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 Spain. 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?

Reduction ratios of lambda immunoglobulin free light chains (λ-FLC) (time frame: Week 12). The study lists 5 primary outcomes in all. 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 NCT03499691, 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 13 Mar 2025.

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