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

End Stage Renal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03499691
• Other study ID #: BXU012191
• Status: Completed
• Phase: N/A
• Start date: April 11, 2018
• Est. completion date: October 4, 2018

Study information

• Verified date: February 2022
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: October 4, 2018
• Est. primary completion date: October 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Device:
• Theranova 500 medium cut-off dialyzer
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
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.

Locations

Country	Name	City	State
Spain	RTS Murcia VII, RTS Servicios de Diálisis S.L.U.	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation

Country where clinical trial is conducted

Spain, 

References & 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: 10.1111/1744-9987.137 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction ratios of lambda immunoglobulin free light chains (?-FLC)		Week 12
Primary	Reduction ratios of kappa immunoglobulin free light chains (k-FLC)		Week 12
Primary	Reduction ratios of chitinase-3-like protein 1 (YKL-40)		Week 12
Primary	Reduction ratios of fibroblast growth factor 23 (FGF-23)		Week 12
Primary	Reduction ratios of serum beta-2 microglobulin (ß2M)		Week 12
Secondary	Change from baseline in mid-week pre-dialysis serum levels of ?-FLC, ?-FLC, YKL-40, FGF-23, ß2M		Week 12 and 24
Secondary	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
Secondary	Percent change from pre- to post-dialysis in mid-week serum levels of hs-CRP		Week 12
Secondary	Percent change from pre- to post-dialysis in mid-week serum levels of PTX-3		Week 12
Secondary	Percent change from pre- to post-dialysis in mid-week serum levels of IL-6		Week 12
Secondary	Percent change from pre- to post-dialysis in mid-week serum levels of IL-10		Week 12
Secondary	Change from baseline in mid-week pre-dialysis serum level of fibrinogen		Week 12 and 24
Secondary	Change from baseline in mid-week pre-dialysis serum level of albumin		Week 12 and 24
Secondary	Single pool Kt/Vurea		Week 24
Secondary	Serum phosphorous		Week 24
Secondary	Kidney Disease Quality of Life 36 (KDQOL-36)		Baseline, Week 12, Week 24
Secondary	Dialysis Symptom Index (DSI)		Baseline, Week 12, Week 24
Secondary	Serum ferritin		Baseline, Week 12, Week 24
Secondary	Transferrin Saturation (TSAT)		Baseline, Week 12, Week 24
Secondary	24-hour urine output on monthly basis		Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
Secondary	Erythropoiesis stimulating agent (ESA) responsiveness		Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Secondary	Hemoglobin levels		Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Secondary	ESA dosage by type, administration frequency, and route		Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Secondary	Intravenous iron dosage		Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Secondary	Number of adverse events of hospitalization, cardiovascular events, and infective episodes		Week 1 through Week 24
Secondary	Total patient death		Week 1 through Week 24