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

NCT02377622 | Completed

• 1 other identifier: 1407-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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)

• Clearance of other middle sized molecules

  Five (5) hours (for each mid-week dialysis session)

• Hematology ( blood cell counts; hematocrit and hemoglobin)

  Five (5) hours ( for each mid-week dialysis session)

Study Arms (4)

THERANOVA 400 dialyzer prototype AA

EXPERIMENTAL

THERANOVA 400 dialyzer prototype AA in hemodialysis

Device: THERANOVA 400 dialyzer prototype AA

THERANOVA 400 dialyzer prototype BB

EXPERIMENTAL

THERANOVA 400 dialyzer prototype BB in hemodialysis

Device: THERANOVA 400 dialyzer prototype BB

FX CorDiax 80 dialyzer

ACTIVE COMPARATOR

FX CorDiax 80 dialyzer in hemodialysis

Device: FX CorDiax 80 Dialyzer

FX CorDiax 800 dialyzer

ACTIVE COMPARATOR

FX CorDiax 800 dialyzer in high volume hemodiafiltration

Device: FX CorDiax 800 Dialyzer

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \. 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vantive Health LLC: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Dialysexentrum Elsenfeld

Elsenfeld, 63820, Germany

Location

Related Publications (2)

• 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.

  PMID: 27587605 RESULT

• 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.

  PMID: 28910799 RESULT

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Torsten Böhler, Manager

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2015
• First Posted: March 3, 2015
• Study Start: February 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: May 1, 2015
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

DE (1)