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NCT Number: NCT03499691

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.

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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Murcia, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Theranova 500 medium cut-off dialyzer

Device

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.

Hemodiafiltration

Device

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.

Primary outcomes

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

    Time frame: Week 12

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

    Time frame: Week 12

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

    Time frame: Week 12

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

    Time frame: Week 12

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

    Time frame: Week 12

Secondary outcomes

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

    Time frame: 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)

    Time frame: Week 12 and 24

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

    Time frame: Week 12

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

    Time frame: Week 12

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

    Time frame: Week 12

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

    Time frame: Week 12

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

    Time frame: Week 12 and 24

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

    Time frame: Week 12 and 24

  9. Single pool Kt/Vurea

    Time frame: Week 24

  10. Serum phosphorous

    Time frame: Week 24

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

    Time frame: Baseline, Week 12, Week 24

  12. Dialysis Symptom Index (DSI)

    Time frame: Baseline, Week 12, Week 24

  13. Serum ferritin

    Time frame: Baseline, Week 12, Week 24

  14. Transferrin Saturation (TSAT)

    Time frame: Baseline, Week 12, Week 24

  15. 24-hour urine output on monthly basis

    Time frame: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6

  16. Erythropoiesis stimulating agent (ESA) responsiveness

    Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

  17. Hemoglobin levels

    Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

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

    Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

  19. Intravenous iron dosage

    Time frame: 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

    Time frame: Week 1 through Week 24

  21. Total patient death

    Time frame: Week 1 through Week 24

Sponsors and collaborators

Lead sponsor

Vantive Health LLC

Industry

Collaborators

  • Baxter Healthcare Corporation

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 17, 2018
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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