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

NCT ID: NCT03499691

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-11
• Study Completion Date: 2018-10-04

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Expanded Hemodialysis (HDx) Therapy

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

Group Type: EXPERIMENTAL

Theranova 500 medium cut-off dialyzer

Intervention Type: 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.

Hemodiafiltration (HDF) Therapy

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

Group Type: ACTIVE_COMPARATOR

Hemodiafiltration

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: collaborator

Vantive Health LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Murcia, , Spain

Countries

Spain

References

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.

Reference Type: RESULT

PMID: 34125503 (View on PubMed)

Other Identifiers

BXU012191

Identifier Type: -

Identifier Source: org_study_id