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

NCT03499691 | Completed

• 1 other identifier: BXU012191
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (5)

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

  Week 12

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

  Week 12

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

  Week 12

• Reduction ratios of fibroblast growth factor 23 (FGF-23)

  Week 12

• Reduction ratios of serum beta-2 microglobulin (β2M)

  Week 12

Secondary Outcomes (21)

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

  Week 12 and 24

• 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)

  Week 12 and 24

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

  Week 12

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

  Week 12

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

  Week 12

Study Arms (2)

Expanded Hemodialysis (HDx) Therapy

EXPERIMENTAL

Patients will undergo 3 dialysis sessions per week with Theranova 500 for up to 24 weeks.

Device: Theranova 500 medium cut-off dialyzer

Hemodiafiltration (HDF) Therapy

ACTIVE COMPARATOR

Patients will undergo 3 dialysis sessions per week with on-line HDF for up to 24 weeks.

Device: Hemodiafiltration

Interventions

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.

Expanded Hemodialysis (HDx) Therapy

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.

Hemodiafiltration (HDF) Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vantive Health LLC: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

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

Murcia, Spain

Location

Related Publications (1)

• 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.

  PMID: 34125503 RESULT

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Hemodiafiltration

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Renal Dialysis; Renal Replacement Therapy; Therapeutics; Sorption Detoxification; Hemofiltration; Extracorporeal Circulation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 17, 2018
• Study Start: April 11, 2018
• Primary Completion: October 4, 2018
• Study Completion: October 4, 2018
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

ES (1)