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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Device: THERANOVA 400 dialyzer prototype AA
* Device: THERANOVA 400 dialyzer prototype BB
* Device: FX CorDiax 80 Dialyzer
* Device: FX CorDiax 800 Dialyzer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: THERANOVA 400 dialyzer prototype AA<br>THERANOVA 400 dialyzer prototype AA in hemodialysis | Device: THERANOVA 400 dialyzer prototype AA<br> <br> |
| Experimental: THERANOVA 400 dialyzer prototype BB<br>THERANOVA 400 dialyzer prototype BB in hemodialysis | Device: THERANOVA 400 dialyzer prototype BB<br> <br> |
| Active Comparator: FX CorDiax 80 dialyzer<br>FX CorDiax 80 dialyzer in hemodialysis | Device: FX CorDiax 80 Dialyzer<br> <br> |
| Active Comparator: FX CorDiax 800 dialyzer<br>FX CorDiax 800 dialyzer in high volume hemodiafiltration | Device: FX CorDiax 800 Dialyzer<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall clearance of lambda FLC clearance | Blood and dialysate | Five (5) hours ( for each mid-week dialysis session) | 
| Overall albumin loss | Dialysate | Five (5) hours (for each mid-week dialysis session) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Five (5) hours (for each mid-week dialysis session) | 
| Hematology ( blood cell counts; hematocrit and hemoglobin) | Blood | Five (5) hours ( for each mid-week dialysis session) |