End Stage Renal DiseaseNCT03257410
Theranova 400 Dialyzer In End Stage Renal Disease (ESRD) Patients
A study testing Theranova 400 dialyzer and Elisio-17H dialyzer in people with End Stage Renal Disease, run by Vantive Health LLC at 20 sites in United States.
Trial summary
The study evaluates the efficacy and safety of the Theranova 400 dialyzer compared with Elisio-17 H dialyzer in end stage renal disease patients receiving hemodialysis treatment. Efficacy will be determined by the removal of middle molecules (with different molecular size) from the blood compartment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Theranova 400 dialyzer and Elisio-17H dialyzer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 20 sitesUnited States
- Study dates
- 29 Sep 2017to 27 Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ESRD patients age 22 and older, or between ages 18 and 21 with a weight ≥ 40kg.
- 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.
Who cannot join
- Are female and pregnant, lactating, or planning to become pregnant during the study period. Note: Female subjects of childbearing potential, defined as a woman <55 years old who has not had a partial or full hysterectomy or oophorectomy, must have a negative serum beta human chorionic gonadotropin (β-hCG) pregnancy test at screening. Subjects of childbearing potential must use a medically acceptable means of contraception during their participation in the study.
- 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.
Show all 21Show fewer
- 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.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Dialysis Center, Inc. Albany
Albany, Georgia, 31701
Dialysis Center, Inc. Kidney Associates of Kansas City
Belton, Missouri, 64012
DaVita Inc, Greater Hartford Nephrology
Bloomfield, Connecticut, 06002
Dialysis Center, Inc. Boston
Boston, Massachusetts, 02111
DaVita Inc., Norfolk Dialysis
Chesapeake, Virginia, 23320
DaVita Corona
Corona, California, 92881
DaVita Inc., Transmountain Dialysis
El Paso, Texas, 79902
DaVita Inc., Medical Center Dialysis
Houston, Texas, 77004
Dialysis Center, Inc. Holston River Clinic
Knoxville, Tennessee, 37924
DaVita Five Star Dialysis Center
Las Vegas, Nevada, 89128
DaVita Inc., South Las Vegas Dialysis
Las Vegas, Nevada, 89169
DaVita Renal Center of Lewisville
Lewisville, Texas, 75057
Dialysis Center of Lincoln
Lincoln, Nebraska, 68510
DaVita Inc., Waterbury Dialysis
Middlebury, Connecticut, 06762
Dialysis Center, Inc. North Brunswick
North Brunswick, New Jersey, 08902
Dialysis Center, Inc. Philidelphia
Philadelphia, Pennsylvania, 19129
DaVita Riverside
Riverside, California, 92501
DaVita Inc., Northwest Medical Center Dialysis
San Antonio, Texas, 78229
DaVita Floyd Curl Dialysis
San Antonio, Texas, 78240
DaVita Inc., Bronx Dialysis Center
The Bronx, New York, 10461
About this study
Official title: A Multi-Center, Prospective, Randomized, Controlled, Open-label, Parallel Study to Evaluate the Safety and Efficacy of the Theranova 400 Dialyzer In End Stage Renal Disease (ESRD) Patients
The study evaluates the efficacy and safety of the Theranova 400 dialyzer compared with Elisio-17 H dialyzer in end stage renal disease patients receiving hemodialysis treatment. Efficacy will be determined by the removal of middle molecules (with different molecular size) from the blood compartment. Safety will be evaluated by maintaining pre-dialysis serum albumin levels and other safety events including laboratory tests and adverse events.
Patients will undergo 3 dialysis sessions per week, for 24 weeks.
- Conditions
- End Stage Renal Disease
- Being tested
- Theranova 400 dialyzer, Elisio-17H dialyzer
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theranova 400 dialyzerDevice
Also called MCO-Ci 400 Dialyzer, medium cut-off dialysis membrane
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 dialyzerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Theranova 400 | Experimental | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Receives: Device: Theranova 400 dialyzer |
| Elisio-17H | Active comparator | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Receives: Device: Elisio-17H dialyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction Ratio of Lambda Immunoglobulin FLC at Week 24
FLC=free light chains
Measured: Week 24
Pre-dialysis Serum Level of Albumin at Week 24
Measured: Week 24
Secondary outcomes (66)
Reduction Ratio of Lambda Immunoglobulin FLC at Week 4 and Week 24
FLC=free light chains
Measured: Week 4 and Week 24
Reduction Ratio of Complement Factor D
CFD=complement factor D
Measured: Week 4 and 24
Reduction Ratio of κ FLC
κ FLC = Kappa Free light chains
Measured: Week 4 and 24
Reduction Ratio of Interleukin 6
IL-6=interleukin 6
Measured: Week 4 and 24
Reduction Ratio of Tumor Necrosis Factor Alpha
TNFα=tumor necrosis factor alpha
Measured: Week 4 and 24
Reduction Ratio of β2-microglobulin
β2=beta 2
Measured: Week 4 and 24
Change From Baseline in Pre-dialysis β2-microglobulin at Week 24
Measured: Baseline, Week 24
Kt/Vurea
Kt/Vurea = Dimensionless number used to quantify hemodialysis and peritoneal dialysis adequacy.
Measured: Week 4, 8, 12, 16, 20, 24
Change From Baseline in Pre-dialysis Serum Albumin by Visit
Measured: Baseline, Week 4, 8, 12, 16, 20, 24
Change From Baseline in Pre-dialysis Factor VII by Visit
Measured: Baseline, Week 12, Week 24
Change From Baseline in Pre-dialysis Protein C by Visit
Measured: Baseline, Week 12, Week 24
Change From Baseline in Pre-dialysis Vitamin A by Visit
Measured: Baseline, Week 4, Week 24
nPNA (nPCR)
nPNA=normalized Protein equivalent of Nitrogen Appearance, and nPCR=normalized Protein Catabolic Rate.
Measured: Week 4, 8, 12, 16, 20, 24
Change From Baseline in Pre-dialysis Factor II by Visit
Factor II (Prothrombin)
Measured: Baseline, Week 12, Week 24
Change From Baseline in Sodium (mmol/L) at End of Study (up to Week 24)
Measured: Baseline and Week 24
Change From Baseline in Potassium (mmol/L) at End of Study (up to Week 24)
Measured: Baseline and Week 24
Change From Baseline in Calcium (mmol/L) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Phosphate (mmol/L) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Chloride (mmol/L) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Bicarbonate (mmol/L) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Glucose (mmol/L) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Prothrombin Time (Sec) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Prothrombin Intl. Normalized Ratio at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Activated Partial Thromboplastin Time (Sec) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Hematocrit (L/L) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Hemoglobin (g/L) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin (pg) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Erythrocyte Mean Corpuscular HGB Concentration (g/L) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Erythrocyte Mean Corpuscular Volume (fL) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Platelets at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Erythrocytes at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Leukocytes at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Basophils (%) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Eosinophils (%) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Lymphocytes (%) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Monocytes (%) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Neutrophils (%) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Pre-Dialysis Blood Urea Nitrogen (mmol Urea/L) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Post-Dialysis Blood Urea Nitrogen (mmol Urea/L) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in BUN Reduction Ratio at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Creatinine (μmol/L) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Kt/Vurea by Visit
Measured: Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Change From Baseline in Vitamin A (μmol/L) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Cholesterol (mmol/L) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in HDL Cholesterol (mmol/L) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in LDL Cholesterol (mmol/L) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Triglycerides (mmol/L) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Alkaline Phosphatase (U/L) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Alanine Aminotransferase (U/L) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Aspartate Aminotransferase (U/L) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Direct Bilirubin (μmol/L) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Bilirubin (μmol/L) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Gamma Glutamyl Transferase (U/L) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Protein (g/L) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Globulin (g/L) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in High-sensitivity C-reactive Protein (mg/L) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Prothrombin Activity (%) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Albumin (g/dL) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Factor XIV Activity (%) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Tumor Necrosis Factor (pg/mL) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Factor VII Activity (%) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Lambda Light Chain, Free (mg/L) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Interleukin 6 (pg/mL) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Complement Factor D (mcg/mL) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Kappa Light Chain, Free (mg/L) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Change From Baseline in Beta-2 Microglobulin (mg/L) at End of Study (up to Week 24)
Measured: Baseline, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start29 Sep 2017
- Primary completion27 Oct 2018
- Study completion27 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantive Health LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257410
- Sponsor's protocol ID
- 7905001
- Status last verified
- Jul 2025
- First submitted
- 18 Aug 2017
- Last updated
- 14 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 32843372
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Prospective, Randomized, Controlled, Open-label, Parallel Study to Evaluate the Safety and Efficacy of the Theranova 400 Dialyzer In End Stage Renal Disease (ESRD) Patients
- ClinicalTrials.gov ID
- NCT03257410
- Acronym / sponsor ID
- 7905001
- Conditions
- End Stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Vantive Health LLCIndustry (pharma, biotech, devices)
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 29 Sep 2017 (actual)
- Primary completion
- 27 Oct 2018 (actual)
- Study completion
- 27 Oct 2018 (actual)
- First posted
- 22 Aug 2017 (actual)
- Results
- Posted 19 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study evaluates the efficacy and safety of the Theranova 400 dialyzer compared with Elisio-17 H dialyzer in end stage renal disease patients receiving hemodialysis treatment. Efficacy will be determined by the removal of middle molecules (with different molecular size) from the blood compartment. Safety will be evaluated by maintaining pre-dialysis serum albumin levels and other safety events including laboratory tests and adverse events.
Patients will undergo 3 dialysis sessions per week, for 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Theranova 400 | Experimental | Device: Theranova 400 dialyzerThree (3) dialysis sessions per week in an in-center setting over 24-week period. |
| Elisio-17H | Active comparator | Device: Elisio-17H dialyzerThree (3) dialysis sessions per week in an in-center setting over 24-week period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ESRD patients age 22 and older, or between ages 18 and 21 with a weight ≥ 40kg.
- 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.
Key exclusion criteria (21 listed)
- Are female and pregnant, lactating, or planning to become pregnant during the study period. Note: Female subjects of childbearing potential, defined as a woman <55 years old who has not had a partial or full hysterectomy or oophorectomy, must have a negative serum beta human chorionic gonadotropin (β-hCG) pregnancy test at screening. Subjects of childbearing potential must use a medically acceptable means of contraception during their participation in the study.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Theranova 400 dialyzerAlso: MCO-Ci 400 Dialyzer, medium cut-off dialysis membranePatients 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. | Device | Theranova 400 |
| Elisio-17H dialyzerPatients 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. | Device | Elisio-17H |
Primary outcome
Reduction Ratio of Lambda Immunoglobulin FLC at Week 24
Time frame: Week 24
FLC=free light chains
Pre-dialysis Serum Level of Albumin at Week 24
Time frame: Week 24
66 secondary outcomes
Reduction Ratio of Lambda Immunoglobulin FLC at Week 4 and Week 24
Time frame: Week 4 and Week 24
Reduction Ratio of Complement Factor D
Time frame: Week 4 and 24
Reduction Ratio of κ FLC
Time frame: Week 4 and 24
Reduction Ratio of Interleukin 6
Time frame: Week 4 and 24
Reduction Ratio of Tumor Necrosis Factor Alpha
Time frame: Week 4 and 24
Reduction Ratio of β2-microglobulin
Time frame: Week 4 and 24
Change From Baseline in Pre-dialysis β2-microglobulin at Week 24
Time frame: Baseline, Week 24
Kt/Vurea
Time frame: Week 4, 8, 12, 16, 20, 24
Change From Baseline in Pre-dialysis Serum Albumin by Visit
Time frame: Baseline, Week 4, 8, 12, 16, 20, 24
Change From Baseline in Pre-dialysis Factor VII by Visit
Time frame: Baseline, Week 12, Week 24
Change From Baseline in Pre-dialysis Protein C by Visit
Time frame: Baseline, Week 12, Week 24
Change From Baseline in Pre-dialysis Vitamin A by Visit
Time frame: Baseline, Week 4, Week 24
nPNA (nPCR)
Time frame: Week 4, 8, 12, 16, 20, 24
Change From Baseline in Pre-dialysis Factor II by Visit
Time frame: Baseline, Week 12, Week 24
Change From Baseline in Sodium (mmol/L) at End of Study (up to Week 24)
Time frame: Baseline and Week 24
Change From Baseline in Potassium (mmol/L) at End of Study (up to Week 24)
Time frame: Baseline and Week 24
Change From Baseline in Calcium (mmol/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Change From Baseline in Phosphate (mmol/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Change From Baseline in Chloride (mmol/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Change From Baseline in Bicarbonate (mmol/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Change From Baseline in Glucose (mmol/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Change From Baseline in Prothrombin Time (Sec) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Change From Baseline in Prothrombin Intl. Normalized Ratio at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Change From Baseline in Activated Partial Thromboplastin Time (Sec) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Change From Baseline in Hematocrit (L/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Change From Baseline in Hemoglobin (g/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin (pg) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Change From Baseline in Erythrocyte Mean Corpuscular HGB Concentration (g/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Change From Baseline in Erythrocyte Mean Corpuscular Volume (fL) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Change From Baseline in Platelets at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Change From Baseline in Erythrocytes at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Change From Baseline in Leukocytes at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Change From Baseline in Basophils (%) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Change From Baseline in Eosinophils (%) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Change From Baseline in Lymphocytes (%) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Change From Baseline in Monocytes (%) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Change From Baseline in Neutrophils (%) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Change From Baseline in Pre-Dialysis Blood Urea Nitrogen (mmol Urea/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Change From Baseline in Post-Dialysis Blood Urea Nitrogen (mmol Urea/L) at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Change From Baseline in BUN Reduction Ratio at End of Study (up to Week 24)
Time frame: Baseline, Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32843372Weiner 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theranova 400 dialyzer and Elisio-17H dialyzer in people with End Stage Renal Disease, run by Vantive Health LLC at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction Ratio of Lambda Immunoglobulin FLC at Week 24 (time frame: Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03257410, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.