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Comparison of the Clinical Performance of 3 THERANOVA 400 Dialyzer Prototypes With a High-Flux Dialyzer in Hemodialysis Mode

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ClinicalTrials.gov Identifier: NCT02377570
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : July 10, 2015
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. Three different Theranova 400 prototypes (AA, BB and CC) operated in hemodialysis mode will be compared with a Cordiax FX-80 dialyzer, operated in hemodialysis 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: THERNOVA 400 dialyzer prototype CC Device: FX CorDiax 80 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 3 THERANOVA 400 Dialyzer Prototypes With a High-Flux Dialyzer in Hemodialysis Mode - A Pilot Study
Study Start Date : March 2015
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: THERANOVA 400 dialyzer prototype AA
THERANOVA 400 dialyzer prototype AA in hemodialysis treatment
Device: THERANOVA 400 dialyzer prototype AA
Hemodialysis

Experimental: THERANOVA 400 dialyzer prototype BB
THERANOVA 400 dialyzer prototype BB in hemodialysis treatment
Device: THERANOVA 400 dialyzer prototype BB
Hemodialysis

Experimental: THERANOVA 400 dialyzer prototype CC
THERANOVA 400 dialyzer prototype CC in hemodialysis treatment
Device: THERNOVA 400 dialyzer prototype CC
Hemodialysis

Active Comparator: FX CorDiax 80 dialyzer
FX CorDiax 80 dialyzer in hemodialysis treatment
Device: FX CorDiax 80 dialyzer
Hemodialysis




Primary Outcome Measures :
  1. Overall clearance of lambda immunoglobulin free light chains (molecular weight 45 kDa) [ Time Frame: One mid-week dialysis session ]
    The primary efficacy endpoint is the overall clearance of lambda immunoglobulin free light chains during a mid-week hemodialysis session, assessed once with each experimental and active comparator product


Secondary Outcome Measures :
  1. Instantanous clearance of a set of molecules with molecular sizes between 60 Da and 45 kDa [ Time Frame: At 30 min from start of a mid-week dialysis session ]
    One secondary efficacy endpoint is the instantaneous clearance of a set of molecules with molecular sizes from 60 Da to 45 kDa at 30 min after start of a mid-week hemodialysis session, assessed once with each experimental and active comparator product

  2. Instantanous clearance of a set of molecules with molecular sizes between 60 Da and 45 kDa [ Time Frame: at 120 min from start of a mid-week dialysis session ]
    One secondary efficacy endpoint is the instantaneous clearance of a set of molecules with molecular sizes from 60 Da to 45 kDa at 120 min after start of a mid-week hemodialysis session, assessed once with each experimental and active comparator product

  3. Overall clearance of a set of molecules with molecular sizes between 60 Da and 40 kDa [ Time Frame: One mid-week dialysis session ]
    One secondary efficacy endpoint is the overall clearance of a set of molecules from 60 Da to 40 kDa during one mid-week hemodialysis session, assessed once with each experimental and active comparator product

  4. Total mass removed of a set of molecules with molecular sizes between 60 Da and 45 kDa [ Time Frame: One mid-week dialysis session ]
    One secondary efficacy endpoint is the total mass removed of a set of molecules from 60 Da to 45 kDa during one mid-week hemodialysis session, assessed once with each experimental and active comparator product

  5. Removal rate of a set of molecules with molecular sizes between 60 Da and 45 kDa [ Time Frame: One mid-week dialysis session ]
    One secondary efficacy endpoint is the removal rate of a set of molecules from 60 Da to 45 kDa during one mid-week hemodialysis session, assessed once with each experimental and active comparator product

  6. Total mass removed of albumin [ Time Frame: One mid-week dialysis session ]
    One secondary safety endpoint is the total removed mass of albumin during one mid-week hemodialysis session, assessed once with each experimental and active comparator product

  7. Post- to pre-dialysis changes in a set of hematology parameters (blood cell counts, hematocrit and hemoglobin) [ Time Frame: One mid-week dialysis session ]
    One secondary safety endpoint is the change in hematology parameters during one mid-week hemodialysis session, assessed once with each experimental and active comparator product

  8. Types and frequency of adverse events and device deficiencies as a measure of safety and dialyzer tolerability [ Time Frame: Continuously, from signature of informed consent form until 1 week after last hemodialysis session with an experimental or active comparator product, an expected average of 29 days ]
    Any adverse events and device deficiencies will be recorded.



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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
  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 (Note: Female capable of becoming pregnant [defined as a woman less than 55 years old who has not had partial or full hysterectomy or oophorectomy] must have a negative serum beta human chorionic gonadotropin [β-hCG] test within 2 weeks of first study treatment)
  5. Patient has been receiving HD or HDF therapy (HDF patients are allowed if their treatments during the study can be safely and effectively performed with HD) 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, Gore-Tex graft, or double-lumen central venous catheter capable of providing a blood flow rate of ≥280 mL/min (with an acceptable recirculation rate, such that solute removal is not likely to be affected) based on the judgment of the treating physician
  7. Patient is in clinically stable condition as judged by the treating physician and as demonstrated by stable medical history for 30 days prior to enrollment, physical examination, and laboratory testing
  8. Patient is willing to comply with the study requirements for therapy during the entire study treatment period
  9. Patient is capable of providing written informed consent to participate in the study

Exclusion Criteria:

  1. Patient is undergoing single-needle dialysis
  2. Patient has an abnormal κ/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 (eg, monoclonal gammopathy of uncertain significance, smouldering [asymptomatic] multiple myeloma, symptomatic multiple myeloma, nonsecretory multiple myeloma, plasmacytomas, or plasma cell leukemia)
  8. Patient has a known polyclonal gammopathy (eg, connective tissue disease, liver disease, chronic infection, lymphoproliferative disorder, or other hematologic condition)
  9. Patient has any other known comorbidity that could, in the opinion of the Investigator, potentially conflict with the study purpose or procedures (eg, severe hypoalbuminemia or anemia)
  10. 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
  11. Patient has a history of non-compliance with the dialysis prescription, as assessed by the Investigator
  12. 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): NCT02377570


Locations
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Austria
LKH-Universität Klinikum Graz, Abteilung für Innere Medizin, Klinische Abteilung für Nephrologie und Dialyse
Graz, Austria, A-8036
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
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Study Director: Ulrike Haug, 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: NCT02377570    
Other Study ID Numbers: 1407-003
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: July 10, 2015
Last Verified: October 2014
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency