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

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

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Device: THERANOVA 400 dialyzer prototype AA; Device: THERANOVA 400 dialyzer prototype BB; Device: FX CorDiax 80 Dialyzer; Device: FX CorDiax 800 Dialyzer

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Elsenfeld, Germany, 63820
    • Dialysexentrum Elsenfeld

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

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:

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Vantive Health LLC
• Collaborators: Baxter Healthcare Corporation
• Investigators: Study Director: Torsten Böhler, Manager, Life Sciences & Operations, Gambro Dialysatoren GmbH (a subsidiary of Baxter International Inc.)

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Nephrol Dial Transplant. 2021 Jul 23;36(8):1555-1556. doi: 10.1093/ndt/gfaa322.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: February 3, 2015
• First Submitted That Met QC Criteria: February 25, 2015
• First Posted (Estimated): March 3, 2015

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: 1407-001