Clinical trial NCT03499691: Exploratory Study to Explore the Safety and Efficacy of the HDx Therapy Using Theranova 500 Dialyzer in Comparison to Hemodiafiltration
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Lead sponsor: Vantive Health LLC
Sponsor class: INDUSTRY
Collaborators: name: Baxter Healthcare Corporation
First posted: 2018-04-17
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Reduction ratios of lambda immunoglobulin free light chains (λ-FLC)
timeFrame: Week 12
measure: Reduction ratios of kappa immunoglobulin free light chains (k-FLC)
timeFrame: Week 12
measure: Reduction ratios of chitinase-3-like protein 1 (YKL-40)
timeFrame: Week 12
measure: Reduction ratios of fibroblast growth factor 23 (FGF-23)
timeFrame: Week 12
measure: Reduction ratios of serum beta-2 microglobulin (β2M)
timeFrame: Week 12
Secondary outcomes:
measure: Change from baseline in mid-week pre-dialysis serum levels of λ-FLC, κ-FLC, YKL-40, FGF-23, ß2M
timeFrame: Week 12 and 24
measure: 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)
timeFrame: Week 12 and 24
measure: Percent change from pre- to post-dialysis in mid-week serum levels of hs-CRP
timeFrame: Week 12
measure: Percent change from pre- to post-dialysis in mid-week serum levels of PTX-3
timeFrame: Week 12
measure: Percent change from pre- to post-dialysis in mid-week serum levels of IL-6
timeFrame: Week 12
measure: Percent change from pre- to post-dialysis in mid-week serum levels of IL-10
timeFrame: Week 12
measure: Change from baseline in mid-week pre-dialysis serum level of fibrinogen
timeFrame: Week 12 and 24
measure: Change from baseline in mid-week pre-dialysis serum level of albumin
timeFrame: Week 12 and 24
measure: Single pool Kt/Vurea
timeFrame: Week 24
measure: Serum phosphorous
timeFrame: Week 24
measure: Kidney Disease Quality of Life 36 (KDQOL-36)
timeFrame: Baseline, Week 12, Week 24
measure: Dialysis Symptom Index (DSI)
timeFrame: Baseline, Week 12, Week 24
measure: Serum ferritin
timeFrame: Baseline, Week 12, Week 24
measure: Transferrin Saturation (TSAT)
timeFrame: Baseline, Week 12, Week 24
measure: 24-hour urine output on monthly basis
timeFrame: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
measure: Erythropoiesis stimulating agent (ESA) responsiveness
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
measure: Hemoglobin levels
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
measure: ESA dosage by type, administration frequency, and route
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
measure: Intravenous iron dosage
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
measure: Number of adverse events of hospitalization, cardiovascular events, and infective episodes
timeFrame: Week 1 through Week 24
measure: Total patient death
timeFrame: Week 1 through Week 24
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: RTS Murcia VII, RTS Servicios de Diálisis S.L.U.
Study officials:
References:
citation: 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.