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

March 11, 2025 updated by: Vantive Health LLC

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Expanded Hemodialysis (HDx) Therapy
Patients will undergo 3 dialysis sessions per week with Theranova 500 for up to 24 weeks.
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.
Active Comparator: Hemodiafiltration (HDF) Therapy
Patients will undergo 3 dialysis sessions per week with on-line HDF for up to 24 weeks.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Reduction ratios of lambda immunoglobulin free light chains (λ-FLC)
Time Frame: Week 12
Week 12
Reduction ratios of kappa immunoglobulin free light chains (k-FLC)
Time Frame: Week 12
Week 12
Reduction ratios of chitinase-3-like protein 1 (YKL-40)
Time Frame: Week 12
Week 12
Reduction ratios of fibroblast growth factor 23 (FGF-23)
Time Frame: Week 12
Week 12
Reduction ratios of serum beta-2 microglobulin (β2M)
Time Frame: Week 12
Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
Week 12 and 24
Percent change from pre- to post-dialysis in mid-week serum levels of hs-CRP
Time Frame: Week 12
Week 12
Percent change from pre- to post-dialysis in mid-week serum levels of PTX-3
Time Frame: Week 12
Week 12
Percent change from pre- to post-dialysis in mid-week serum levels of IL-6
Time Frame: Week 12
Week 12
Percent change from pre- to post-dialysis in mid-week serum levels of IL-10
Time Frame: Week 12
Week 12
Change from baseline in mid-week pre-dialysis serum level of fibrinogen
Time Frame: Week 12 and 24
Week 12 and 24
Change from baseline in mid-week pre-dialysis serum level of albumin
Time Frame: Week 12 and 24
Week 12 and 24
Single pool Kt/Vurea
Time Frame: Week 24
Week 24
Serum phosphorous
Time Frame: Week 24
Week 24
Kidney Disease Quality of Life 36 (KDQOL-36)
Time Frame: Baseline, Week 12, Week 24
Baseline, Week 12, Week 24
Dialysis Symptom Index (DSI)
Time Frame: Baseline, Week 12, Week 24
Baseline, Week 12, Week 24
Serum ferritin
Time Frame: Baseline, Week 12, Week 24
Baseline, Week 12, Week 24
Transferrin Saturation (TSAT)
Time Frame: Baseline, Week 12, Week 24
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
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
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
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
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
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
Week 1 through Week 24
Total patient death
Time Frame: Week 1 through Week 24
Week 1 through Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vantive Health LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Baxter Healthcare Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Baxter Clinical Trials, Baxter Healthcare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 11, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 4, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 4, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BXU012191

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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