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

Vantive Health LLC43 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

End Stage Renal Disease

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: Week 12

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

Time frame: Week 12

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

Time frame: Week 12

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

Time frame: Week 12

Reduction ratios of serum beta-2 microglobulin (β2M)

Time frame: Week 12

Secondary Outcomes

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

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

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

Time frame: Week 12

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

Time frame: Week 12

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

Time frame: Week 12

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

Time frame: Week 12

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

Time frame: Week 12 and 24

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

Time frame: Week 12 and 24

Single pool Kt/Vurea

Time frame: Week 24

Serum phosphorous

Time frame: Week 24

Kidney Disease Quality of Life 36 (KDQOL-36)

Time frame: Baseline, Week 12, Week 24

Dialysis Symptom Index (DSI)

Time frame: Baseline, Week 12, Week 24

Serum ferritin

Time frame: Baseline, Week 12, Week 24

Transferrin Saturation (TSAT)

Time frame: Baseline, Week 12, Week 24

24-hour urine output on monthly basis

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

Erythropoiesis stimulating agent (ESA) responsiveness

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

Hemoglobin levels

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

ESA dosage by type, administration frequency, and route

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

Intravenous iron dosage

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

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

Time frame: Week 1 through Week 24

Total patient death

Time frame: Week 1 through Week 24

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes