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

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ClinicalTrials.gov Identifier: NCT02377622
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : August 26, 2016
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation

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

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Device: THERANOVA 400 dialyzer prototype AA Device: THERANOVA 400 dialyzer prototype BB Device: FX CorDiax 80 Dialyzer Device: FX CorDiax 800 Dialyzer Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2015
Actual Primary Completion Date : April 2015
Actual Study Completion Date : May 2015

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



Primary Outcome Measures :
  1. Overall clearance of lambda FLC clearance [ Time Frame: Five (5) hours ( for each mid-week dialysis session) ]
    Blood and dialysate

  2. Overall albumin loss [ Time Frame: Five (5) hours (for each mid-week dialysis session) ]
    Dialysate


Secondary Outcome Measures :
  1. 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) ]
    All adverse events and device deficiencies will be recorded

  2. Clearance of other middle sized molecules [ Time Frame: Five (5) hours (for each mid-week dialysis session) ]
    Blood and dialysate

  3. Hematology ( blood cell counts; hematocrit and hemoglobin) [ Time Frame: Five (5) hours ( for each mid-week dialysis session) ]
    Blood



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02377622


Locations
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Germany
Dialysexentrum Elsenfeld
Elsenfeld, Germany, 63820
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
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Study Director: Torsten Böhler, Manager Life Sciences & Operations, Gambro Dialysatoren GmbH (a subsidiary of Baxter International Inc.
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Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT02377622    
Other Study ID Numbers: 1407-001
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: August 26, 2016
Last Verified: February 2015
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency