Theranova 400 Dialyzer In End Stage Renal Disease (ESRD) Patients
NCT ID: NCT03257410
Last Updated: 2025-07-14
Study Results
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View full resultsBasic Information
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COMPLETED
NA
172 participants
INTERVENTIONAL
2017-09-29
2018-10-27
Brief Summary
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Patients will undergo 3 dialysis sessions per week, for 24 weeks.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Theranova 400
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Theranova 400 dialyzer
Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
Elisio-17H
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Elisio-17H dialyzer
Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
Interventions
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Theranova 400 dialyzer
Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
Elisio-17H dialyzer
Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinically stable as judged by the treating physician and as demonstrated by stable medical history for 30 days prior to enrollment, physical examination, and laboratory testing.
* Hemodialysis therapy with high-flux dialyzers for at least 3 months immediately prior to study enrollment and expected to survive for the next 12 months.
* Expected to maintain an acceptable urea clearance (Kt/V) with a dialyzer of an approximate surface area of 1.7 m2.
* Currently being dialyzed at an in-center setting, on a schedule of 3 times per week.
* Able to give informed consent after an explanation of the proposed study, and who are willing to comply with the study requirements for therapy during the entire study treatment period.
* Have a stable functioning vascular access (arteriovenous fistula, graft, or dual lumen tunneled catheter); stable access will be confirmed by observed Kt/V \>= 1.2 for past 2 measurements, and/or achievement of within 15% the prescribed blood flow rate over 3 treatments prior to study entry.
Exclusion Criteria
* Have chronic liver disease.
* Have a known paraprotein-associated disease.
* Have known bleeding disorders (e.g., gastrointestinal bleed, colonic polyps, small bowel angiodysplasia, and active peptic ulcers).
* Have had a major bleeding episode (i.e. soft tissue bleeding, blood in stool, prolonged nose bleeds, joint damage, retinal bleeding, extensive mucosal bleeding, exsanguination, cerebral hemorrhage) ≤ 12 weeks prior to randomization.
* Have had a blood (red blood cell) transfusion ≤ 12 weeks prior to randomization.
* Have had an acute infection ≤ 4 weeks prior to randomization.
* Have active cancer, except for basal cell or squamous cell skin cancer.
* Have a known serum κ/λ FLC ratio that is less than 0.37, or greater than 3.1.b
* Have a known monoclonal gammopathy (monoclonal gammopathy of uncertain significance, smoldering \[asymptomatic\] multiple myeloma, symptomatic multiple myeloma, plasmacytomas, or plasma cell leukemia).
* Have a known polyclonal gammopathy (connective tissue disease, liver disease, chronic infection, lymphoproliferative disorder, or other hematologic condition).
* Have a positive serology test for human immunodeficiency virus or hepatitis infection.
* Have a significant psychiatric disorder or mental disability.
* Are scheduled for planned interventions requiring hospitalization \> 1 week.
* Are scheduled for living-donor transplantation within the study period + 3 months, plan to change to PD therapy within the next 9 months, plan to change to a home hemodialysis treatment, or plan to relocate to an area where no study center is located.
* Are currently participating in another interventional clinical study or has participated in another interventional clinical study in the past 3 months.
* Have a history of non-compliance with HD as assessed by an investigator.
* Have had a major cardiovascular or cerebrovascular event within 3 months of study entry.
* Have a history with consistent evidence of intradialytic hypotension.
* Have uncontrolled (systolic BP \> 180 mmHg) hypertension.
* Have had adverse reactions to dialyzer materials.
18 Years
ALL
No
Sponsors
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Baxter Healthcare Corporation
INDUSTRY
Vantive Health LLC
INDUSTRY
Responsible Party
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Locations
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DaVita Corona
Corona, California, United States
DaVita Riverside
Riverside, California, United States
DaVita Inc, Greater Hartford Nephrology
Bloomfield, Connecticut, United States
DaVita Inc., Waterbury Dialysis
Middlebury, Connecticut, United States
Dialysis Center, Inc. Albany
Albany, Georgia, United States
Dialysis Center, Inc. Boston
Boston, Massachusetts, United States
Dialysis Center, Inc. Kidney Associates of Kansas City
Belton, Missouri, United States
Dialysis Center of Lincoln
Lincoln, Nebraska, United States
DaVita Five Star Dialysis Center
Las Vegas, Nevada, United States
DaVita Inc., South Las Vegas Dialysis
Las Vegas, Nevada, United States
Dialysis Center, Inc. North Brunswick
North Brunswick, New Jersey, United States
DaVita Inc., Bronx Dialysis Center
The Bronx, New York, United States
Dialysis Center, Inc. Philidelphia
Philadelphia, Pennsylvania, United States
Dialysis Center, Inc. Holston River Clinic
Knoxville, Tennessee, United States
DaVita Inc., Transmountain Dialysis
El Paso, Texas, United States
DaVita Inc., Medical Center Dialysis
Houston, Texas, United States
DaVita Renal Center of Lewisville
Lewisville, Texas, United States
DaVita Inc., Northwest Medical Center Dialysis
San Antonio, Texas, United States
DaVita Floyd Curl Dialysis
San Antonio, Texas, United States
DaVita Inc., Norfolk Dialysis
Chesapeake, Virginia, United States
Countries
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References
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Weiner DE, Falzon L, Skoufos L, Bernardo A, Beck W, Xiao M, Tran H. Efficacy and Safety of Expanded Hemodialysis with the Theranova 400 Dialyzer: A Randomized Controlled Trial. Clin J Am Soc Nephrol. 2020 Sep 7;15(9):1310-1319. doi: 10.2215/CJN.01210120. Epub 2020 Aug 25.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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7905001
Identifier Type: -
Identifier Source: org_study_id
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