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

Primary Purpose

End Stage Renal Disease

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Theranova 500 medium cut-off dialyzer

Hemodiafiltration

About this trial

This is an interventional treatment trial for End Stage Renal Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Expanded Hemodialysis (HDx) Therapy

Hemodiafiltration (HDF) Therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

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

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

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

Reduction ratios of serum beta-2 microglobulin (β2M)

Secondary Outcome Measures

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

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)

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

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

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

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

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

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

Single pool Kt/Vurea

Serum phosphorous

Kidney Disease Quality of Life 36 (KDQOL-36)

Dialysis Symptom Index (DSI)

Serum ferritin

Transferrin Saturation (TSAT)

24-hour urine output on monthly basis

Erythropoiesis stimulating agent (ESA) responsiveness

Hemoglobin levels

ESA dosage by type, administration frequency, and route

Intravenous iron dosage

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

Total patient death

Full Information

NCT ID

NCT03499691

First Posted

April 9, 2018

Last Updated

February 17, 2022

Sponsor

Baxter Healthcare Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03499691

Brief Title

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

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

April 11, 2018 (Actual)

Primary Completion Date

October 4, 2018 (Actual)

Study Completion Date

October 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Baxter Healthcare Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End Stage Renal Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Expanded Hemodialysis (HDx) Therapy

Arm Type

Experimental

Arm Description

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

Arm Title

Hemodiafiltration (HDF) Therapy

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Theranova 500 medium cut-off dialyzer

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Hemodiafiltration

Intervention Description

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 Outcome Measure Information:

Title

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

Time Frame

Week 12

Title

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

Time Frame

Week 12

Title

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

Time Frame

Week 12

Title

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

Time Frame

Week 12

Title

Reduction ratios of serum beta-2 microglobulin (β2M)

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

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

Title

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

Title

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

Time Frame

Week 12

Title

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

Time Frame

Week 12

Title

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

Time Frame

Week 12

Title

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

Time Frame

Week 12

Title

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

Time Frame

Week 12 and 24

Title

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

Time Frame

Week 12 and 24

Title

Single pool Kt/Vurea

Time Frame

Week 24

Title

Serum phosphorous

Time Frame

Week 24

Title

Kidney Disease Quality of Life 36 (KDQOL-36)

Time Frame

Baseline, Week 12, Week 24

Title

Dialysis Symptom Index (DSI)

Time Frame

Baseline, Week 12, Week 24

Title

Serum ferritin

Time Frame

Baseline, Week 12, Week 24

Title

Transferrin Saturation (TSAT)

Time Frame

Baseline, Week 12, Week 24

Title

24-hour urine output on monthly basis

Time Frame

Month 1, Month 2, Month 3, Month 4, Month 5, Month 6

Title

Erythropoiesis stimulating agent (ESA) responsiveness

Time Frame

Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

Title

Hemoglobin levels

Time Frame

Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

Title

ESA dosage by type, administration frequency, and route

Time Frame

Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

Title

Intravenous iron dosage

Time Frame

Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

Title

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

Time Frame

Week 1 through Week 24

Title

Total patient death

Time Frame

Week 1 through Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Baxter Clinical Trials

Organizational Affiliation

Baxter Healthcare

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Murcia

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

34125503

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.

Results Reference

result

Learn more about this trial

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

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