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End Stage Renal DiseaseNCT02377570

Comparison of the Clinical Performance of 3 THERANOVA 400 Dialyzer Prototypes With a High-Flux Dialyzer in Hemodialysis Mode

A study testing THERANOVA 400 dialyzer prototype AA, THERANOVA 400 dialyzer prototype BB and THERNOVA 400 dialyzer prototype CC in people with End Stage Renal Disease, run by Vantive Health LLC at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study investigates the performance of a new dialyzer (Theranova 400) containing a membrane with increased pore sizes. The performance will be determined by the removal of middle molecules (with different molecular size) from the blood compartment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
End Stage Renal Disease
What is being tested?
THERANOVA 400 dialyzer prototype AA, THERANOVA 400 dialyzer prototype BB and THERNOVA 400 dialyzer prototype CC
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteAustria
Study dates
Mar 2015to May 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient has end-stage renal disease
  • Patient is 18 years of age or older
  • Patient is male or female
  • Patient, if female, is non-pregnant; and if capable of becoming pregnant, will be using a medically acceptable means of contraception during participation in the study (Note: Female capable of becoming pregnant [defined as a woman less than 55 years old who has not had partial or full hysterectomy or oophorectomy] must have a negative serum beta human chorionic gonadotropin [β-hCG] test within 2 weeks of first study treatment)
  • Patient has been receiving HD or HDF therapy (HDF patients are allowed if their treatments during the study can be safely and effectively performed with HD) for ≥3 months prior to study enrollment and is expected to survive for at least 12 months after enrollment
  • Patient has a stable functioning native fistula, Gore-Tex graft, or double-lumen central venous catheter capable of providing a blood flow rate of ≥280 mL/min (with an acceptable recirculation rate, such that solute removal is not likely to be affected) based on the judgment of the treating physician
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  • Patient is in clinically stable condition as judged by the treating physician and as demonstrated by stable medical history for 30 days prior to enrollment, physical examination, and laboratory testing
  • Patient is willing to comply with the study requirements for therapy during the entire study treatment period
  • Patient is capable of providing written informed consent to participate in the study

Who cannot join

  • Patient is undergoing single-needle dialysis
  • Patient has an abnormal κ/λ ratio (less than 0.37, or greater than 3.1)
  • Patient has a known active infection and is currently receiving antibiotic treatment
  • Patient has known active cancer
  • Patient has a known positive serology test for human immunodeficiency virus (HIV) or hepatitis B, C or E
  • Patient has a known serious hemostasis disorder
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  • Patient has a known monoclonal gammopathy (eg, monoclonal gammopathy of uncertain significance, smouldering [asymptomatic] multiple myeloma, symptomatic multiple myeloma, nonsecretory multiple myeloma, plasmacytomas, or plasma cell leukemia)
  • Patient has a known polyclonal gammopathy (eg, connective tissue disease, liver disease, chronic infection, lymphoproliferative disorder, or other hematologic condition)
  • Patient has any other known comorbidity that could, in the opinion of the Investigator, potentially conflict with the study purpose or procedures (eg, severe hypoalbuminemia or anemia)
  • Patient has a known significant psychiatric disorder or mental disability that could interfere with the patient's ability to provide informed consent and/or comply with protocol procedures
  • Patient has a history of non-compliance with the dialysis prescription, as assessed by the Investigator
  • Patient has participated in another interventional clinical study in the past 3 months, or is currently participating in another interventional clinical study

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • LKH-Universität Klinikum Graz, Abteilung für Innere Medizin, Klinische Abteilung für Nephrologie und Dialyse

    Graz, A-8036

Other trials in Austria

About this study

Official title: Comparison of the Clinical Performance of 3 THERANOVA 400 Dialyzer Prototypes With a High-Flux Dialyzer in Hemodialysis Mode - A Pilot Study

The study investigates the performance of a new dialyzer (Theranova 400) containing a membrane with increased pore sizes. The performance will be determined by the removal of middle molecules (with different molecular size) from the blood compartment. Three different Theranova 400 prototypes (AA, BB and CC) operated in hemodialysis mode will be compared with a Cordiax FX-80 dialyzer, operated in hemodialysis mode. Safety events and albumin loss into the dialysate will be monitored

Being tested
THERANOVA 400 dialyzer prototype AA, THERANOVA 400 dialyzer prototype BB, THERNOVA 400 dialyzer prototype CC, FX CorDiax 80 dialyzer
Medical subject headings
Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • THERANOVA 400 dialyzer prototype AADevice

    Hemodialysis

  • THERANOVA 400 dialyzer prototype BBDevice

    Hemodialysis

  • THERNOVA 400 dialyzer prototype CCDevice

    Hemodialysis

  • FX CorDiax 80 dialyzerDevice

    Hemodialysis

Study groups in NCT02377570
Study groupRoleWhat they receive
THERANOVA 400 dialyzer prototype AAExperimentalTHERANOVA 400 dialyzer prototype AA in hemodialysis treatment
Receives: Device: THERANOVA 400 dialyzer prototype AA
THERANOVA 400 dialyzer prototype BBExperimentalTHERANOVA 400 dialyzer prototype BB in hemodialysis treatment
Receives: Device: THERANOVA 400 dialyzer prototype BB
THERANOVA 400 dialyzer prototype CCExperimentalTHERANOVA 400 dialyzer prototype CC in hemodialysis treatment
Receives: Device: THERNOVA 400 dialyzer prototype CC
FX CorDiax 80 dialyzerActive comparatorFX CorDiax 80 dialyzer in hemodialysis treatment
Receives: Device: FX CorDiax 80 dialyzer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall clearance of lambda immunoglobulin free light chains (molecular weight 45 kDa)

    The primary efficacy endpoint is the overall clearance of lambda immunoglobulin free light chains during a mid-week hemodialysis session, assessed once with each experimental and active comparator product

    Measured: One mid-week dialysis session

Secondary outcomes (8)

  1. Instantanous clearance of a set of molecules with molecular sizes between 60 Da and 45 kDa

    One secondary efficacy endpoint is the instantaneous clearance of a set of molecules with molecular sizes from 60 Da to 45 kDa at 30 min after start of a mid-week hemodialysis session, assessed once with each experimental and active comparator product

    Measured: At 30 min from start of a mid-week dialysis session

  2. Instantanous clearance of a set of molecules with molecular sizes between 60 Da and 45 kDa

    One secondary efficacy endpoint is the instantaneous clearance of a set of molecules with molecular sizes from 60 Da to 45 kDa at 120 min after start of a mid-week hemodialysis session, assessed once with each experimental and active comparator product

    Measured: at 120 min from start of a mid-week dialysis session

  3. Overall clearance of a set of molecules with molecular sizes between 60 Da and 40 kDa

    One secondary efficacy endpoint is the overall clearance of a set of molecules from 60 Da to 40 kDa during one mid-week hemodialysis session, assessed once with each experimental and active comparator product

    Measured: One mid-week dialysis session

  4. Total mass removed of a set of molecules with molecular sizes between 60 Da and 45 kDa

    One secondary efficacy endpoint is the total mass removed of a set of molecules from 60 Da to 45 kDa during one mid-week hemodialysis session, assessed once with each experimental and active comparator product

    Measured: One mid-week dialysis session

  5. Removal rate of a set of molecules with molecular sizes between 60 Da and 45 kDa

    One secondary efficacy endpoint is the removal rate of a set of molecules from 60 Da to 45 kDa during one mid-week hemodialysis session, assessed once with each experimental and active comparator product

    Measured: One mid-week dialysis session

  6. Total mass removed of albumin

    One secondary safety endpoint is the total removed mass of albumin during one mid-week hemodialysis session, assessed once with each experimental and active comparator product

    Measured: One mid-week dialysis session

  7. Post- to pre-dialysis changes in a set of hematology parameters (blood cell counts, hematocrit and hemoglobin)

    One secondary safety endpoint is the change in hematology parameters during one mid-week hemodialysis session, assessed once with each experimental and active comparator product

    Measured: One mid-week dialysis session

  8. Types and frequency of adverse events and device deficiencies as a measure of safety and dialyzer tolerability

    Any adverse events and device deficiencies will be recorded.

    Measured: Continuously, from signature of informed consent form until 1 week after last hemodialysis session with an experimental or active comparator product, an expected average of 29 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionMay 2015
  4. Study completionMay 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02377570
Sponsor's protocol ID
1407-003
Status last verified
Mar 2025
First submitted
10 Feb 2015
Last updated
13 Mar 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • Kirsch AH, Lyko R, Nilsson LG, Beck W, Amdahl M, Lechner P, Schneider A, Wanner C, Rosenkranz AR, Krieter DH. Performance of hemodialysis with novel medium cut-off dialyzers. Nephrol Dial Transplant. 2017 Jan 1;32(1):165-172. doi: 10.1093/ndt/gfw310.

    PubMed 27587605

  • Kirsch AH, Rosenkranz AR, Lyko R, Krieter DH. Effects of Hemodialysis Therapy Using Dialyzers with Medium Cut-Off Membranes on Middle Molecules. Contrib Nephrol. 2017;191:158-167. doi: 10.1159/000479264. Epub 2017 Sep 14.

    PubMed 28910799

Questions about this trial

What is this clinical trial studying?

A study testing THERANOVA 400 dialyzer prototype AA, THERANOVA 400 dialyzer prototype BB and THERNOVA 400 dialyzer prototype CC in people with End Stage Renal Disease, run by Vantive Health LLC at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall clearance of lambda immunoglobulin free light chains (molecular weight 45 kDa) (time frame: One mid-week dialysis session). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02377570, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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