End Stage Renal DiseaseNCT02377622

Clinical Performance Comparison of 2 THERANOVA 400 Dialyzer Prototypes in HD With High-Flux Dialyzers in HD and hv HDF Mode

A study testing THERANOVA 400 dialyzer prototype AA, THERANOVA 400 dialyzer prototype BB and FX CorDiax 80 Dialyzer in people with End Stage Renal Disease, run by Vantive Health LLC at 1 site in Germany.

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

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 FX CorDiax 80 Dialyzer
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteGermany
Study dates: Feb 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 (Chronic kidney disease stage 5D)
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 5 .Patient has been receiving HD or HDF therapy for >3 months prior to study enrollment and is expected to survive for at least 12 months after enrollment.
6. Patient has a stable functioning native fistula 7. Patient is willing to comply with the study requirements for therapy during the entire study treatment period 8. Patient is capable fo providing written informed consent to participate in the study

Who cannot join

Patient is undergoing single-needle dialysis
Patient has an known abnormal k/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

Show all 18Show fewer

Patient has a known monoclonal gammopathy
Patient has a known polyclonal gammopathy
Patient has a unstable condition as judged by the treating physician based on medical history, physical examination and laboratory testing including (but not limited to) any of the following:
Myocardial infarction within the last 3 months
Tachyarrhythmia or bradyarrhythmia absoluta
Unstable angina pectoris
Left ventricular ejection fraction <30%
Significant pericardial disease
Patient has any other known comorbidity that could, in the opinion of the Investigator, potentially conflict with the study purpose or procedure
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.

Germany1 site

Dialysexentrum Elsenfeld
Elsenfeld, 63820

Other trials in Germany

About this study

Official title: Comparison of the Clinical Performance of 2 THERANOVA 400 Dialyzer Prototypes in HD With a High-Flux Dialyzer in HD and a High-Flux Dialyzer in hvHDF - 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. Two different Theranova 400 prototypes (AA and BB) operated in hemodialysis mode will be compared with a Cordiax Fx-80 dialyzer, operated in hemodialysis mode, and with a Cordiax Fx-800, operated in high volume hemodiafiltration mode. Safety events and albumin loss into the dialysate will be monitored

Conditions: End Stage Renal Disease
Being tested: THERANOVA 400 dialyzer prototype AA, THERANOVA 400 dialyzer prototype BB, FX CorDiax 80 Dialyzer, FX CorDiax 800 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
THERANOVA 400 dialyzer prototype BBDevice
FX CorDiax 80 DialyzerDevice
FX CorDiax 800 DialyzerDevice

Study groups in NCT02377622
Study group	Role	What they receive
THERANOVA 400 dialyzer prototype AA	Experimental	THERANOVA 400 dialyzer prototype AA in hemodialysis Receives: Device: THERANOVA 400 dialyzer prototype AA
THERANOVA 400 dialyzer prototype BB	Experimental	THERANOVA 400 dialyzer prototype BB in hemodialysis Receives: Device: THERANOVA 400 dialyzer prototype BB
FX CorDiax 80 dialyzer	Active comparator	FX CorDiax 80 dialyzer in hemodialysis Receives: Device: FX CorDiax 80 Dialyzer
FX CorDiax 800 dialyzer	Active comparator	FX CorDiax 800 dialyzer in high volume hemodiafiltration Receives: Device: FX CorDiax 800 Dialyzer

What is being measured

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

Overall clearance of lambda FLC clearance
Blood and dialysate
Measured: Five (5) hours ( for each mid-week dialysis session)
Overall albumin loss
Dialysate
Measured: Five (5) hours (for each mid-week dialysis session)

Secondary outcomes (3)

Types and frequency of adverse events and device deficiencies as a measure of safety and dialyzer tolerability
All adverse events and device deficiencies will be recorded
Measured: Average 60 days (continuously, from signature of informed consent form until 1 week after last hemodialysis session with an experimental or active comparator product)
Clearance of other middle sized molecules
Blood and dialysate
Measured: Five (5) hours (for each mid-week dialysis session)
Hematology ( blood cell counts; hematocrit and hemoglobin)
Blood
Measured: Five (5) hours ( for each mid-week dialysis session)

Timeline

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

Feb 2015May 2015

First posted3 Mar 2015 (estimated)
Study startFeb 2015
Primary completionApr 2015
Study completionMay 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: NCT02377622
Sponsor's protocol ID: 1407-001
Status last verified: Mar 2025
First submitted: 3 Feb 2015
Last updated: 13 Mar 2025
Results posted: No
Data monitoring committee: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All End Stage Renal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the Clinical Performance of 2 THERANOVA 400 Dialyzer Prototypes in HD With a High-Flux Dialyzer in HD and a High-Flux Dialyzer in hvHDF - A Pilot Study
ClinicalTrials.gov ID: NCT02377622
Acronym / sponsor ID: 1407-001
Conditions: End Stage Renal Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Vantive Health LLCIndustry (pharma, biotech, devices)
Collaborators: Baxter Healthcare Corporation
Study start: Feb 2015
Primary completion: Apr 2015 (actual)
Study completion: May 2015 (actual)
First posted: 3 Mar 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
THERANOVA 400 dialyzer prototype AA	Experimental	Device: THERANOVA 400 dialyzer prototype AATHERANOVA 400 dialyzer prototype AA in hemodialysis
THERANOVA 400 dialyzer prototype BB	Experimental	Device: THERANOVA 400 dialyzer prototype BBTHERANOVA 400 dialyzer prototype BB in hemodialysis
FX CorDiax 80 dialyzer	Active comparator	Device: FX CorDiax 80 DialyzerFX CorDiax 80 dialyzer in hemodialysis
FX CorDiax 800 dialyzer	Active comparator	Device: FX CorDiax 800 DialyzerFX CorDiax 800 dialyzer in high volume hemodiafiltration

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patient has end-stage renal disease (Chronic kidney disease stage 5D)
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 5 .Patient has been receiving HD or HDF therapy for >3 months prior to study enrollment and is expected to survive for at least 12 months after enrollment.
6. Patient has a stable functioning native fistula 7. Patient is willing to comply with the study requirements for therapy during the entire study treatment period 8. Patient is capable fo providing written informed consent to participate in the study

Key exclusion criteria (18 listed)

Patient is undergoing single-needle dialysis
Patient has an known abnormal k/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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
THERANOVA 400 dialyzer prototype AA	Device	THERANOVA 400 dialyzer prototype AA
THERANOVA 400 dialyzer prototype BB	Device	THERANOVA 400 dialyzer prototype BB
FX CorDiax 80 Dialyzer	Device	FX CorDiax 80 dialyzer
FX CorDiax 800 Dialyzer	Device	FX CorDiax 800 dialyzer

Primary outcome

Overall clearance of lambda FLC clearance
Time frame: Five (5) hours ( for each mid-week dialysis session)
Blood and dialysate
Overall albumin loss
Time frame: Five (5) hours (for each mid-week dialysis session)
Dialysate

3 secondary outcomes

Types and frequency of adverse events and device deficiencies as a measure of safety and dialyzer tolerability
Time frame: Average 60 days (continuously, from signature of informed consent form until 1 week after last hemodialysis session with an experimental or active comparator product)
Clearance of other middle sized molecules
Time frame: Five (5) hours (for each mid-week dialysis session)
Hematology ( blood cell counts; hematocrit and hemoglobin)
Time frame: Five (5) hours ( for each mid-week dialysis session)

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
Results publication: PubMed 27587605Kirsch 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.
Results publication: PubMed 28910799Kirsch 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.

Related trials for End Stage Renal Disease

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Torsten Böhler, Manager study director

Life Sciences & Operations, Gambro Dialysatoren GmbH (a subsidiary of Baxter International Inc.)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 18 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 Germany. 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 FLC clearance (time frame: Five (5) hours ( for each mid-week dialysis session)). The study lists 2 primary outcomes in all. 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 NCT02377622, 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.