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

Not Applicable

Completed

• Conditions: End Stage Renal Disease
• Interventions: Device: THERANOVA 400 dialyzer prototype BB; Device: FX CorDiax 80 Dialyzer; Device: FX CorDiax 800 Dialyzer; Device: THERANOVA 400 dialyzer prototype AA

• Registration Number: NCT02377622
• Lead Sponsor: Vantive Health LLC

Brief 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. 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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-03
• Study First Submitted QC: 2015-02-25
• Study First Posted: 2015-03-03
• Primary Completion: 2015-04
• Study Completion: 2015-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Patient has end-stage renal disease (Chronic kidney disease stage 5D)

2. Patient is 18 years of age or older

3. Patient is male or female

4. 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.

5. 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

1. Patient is undergoing single-needle dialysis

2. Patient has an known abnormal k/λ ratio (less than 0.37, or greater than 3.1)

3. Patient has a known active infection and is currently receiving antibiotic treatment

4. Patient has known active cancer

5. Patient has a known positive serology test for human immunodeficiency virus (HIV) or hepatitis B,C or E

6. Patient has a known serious hemostasis disorder

7. Patient has a known monoclonal gammopathy

8. Patient has a known polyclonal gammopathy

9. 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

10. Patient has any other known comorbidity that could, in the opinion of the Investigator, potentially conflict with the study purpose or procedure

11. 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

12. Patient has a history of non-compliance with the dialysis prescription, as assessed by the Investigator

13. Patient has participated in another interventional clinical study in the past 3 months, or is currently participating in another interventional clinical study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
THERANOVA 400 dialyzer prototype BB	THERANOVA 400 dialyzer prototype BB	THERANOVA 400 dialyzer prototype BB in hemodialysis
FX CorDiax 80 dialyzer	FX CorDiax 80 Dialyzer	FX CorDiax 80 dialyzer in hemodialysis
FX CorDiax 800 dialyzer	FX CorDiax 800 Dialyzer	FX CorDiax 800 dialyzer in high volume hemodiafiltration
THERANOVA 400 dialyzer prototype AA	THERANOVA 400 dialyzer prototype AA	THERANOVA 400 dialyzer prototype AA in hemodialysis

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dialysexentrum Elsenfeld; 🇩🇪 Elsenfeld, Germany