Theranova 400 Dialyzer In End Stage Renal Disease (ESRD) Patients

NCT03257410 | Completed Results FDA Device

• 1 other identifier: 7905001
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 20

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• Reduction Ratio of Lambda Immunoglobulin FLC at Week 24

  FLC=free light chains

  Week 24

• Pre-dialysis Serum Level of Albumin at Week 24

  Week 24

Secondary Outcomes (66)

• Reduction Ratio of Lambda Immunoglobulin FLC at Week 4 and Week 24

  Week 4 and Week 24

• Reduction Ratio of Complement Factor D

  Week 4 and 24

• Reduction Ratio of κ FLC

  Week 4 and 24

• Reduction Ratio of Interleukin 6

  Week 4 and 24

• Reduction Ratio of Tumor Necrosis Factor Alpha

  Week 4 and 24

Study Arms (2)

Theranova 400

EXPERIMENTAL

Three (3) dialysis sessions per week in an in-center setting over 24-week period.

Device: Theranova 400 dialyzer

Elisio-17H

ACTIVE COMPARATOR

Three (3) dialysis sessions per week in an in-center setting over 24-week period.

Device: Elisio-17H dialyzer

Interventions

Theranova 400 dialyzer DEVICE

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.

Also known as: MCO-Ci 400 Dialyzer, medium cut-off dialysis membrane

Theranova 400

Elisio-17H dialyzer DEVICE

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

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

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

Study Sites (20)

DaVita Corona

Corona, California, 92881, United States

Location

DaVita Riverside

Riverside, California, 92501, United States

Location

DaVita Inc, Greater Hartford Nephrology

Bloomfield, Connecticut, 06002, United States

Location

DaVita Inc., Waterbury Dialysis

Middlebury, Connecticut, 06762, United States

Location

Dialysis Center, Inc. Albany

Albany, Georgia, 31701, United States

Location

Dialysis Center, Inc. Boston

Boston, Massachusetts, 02111, United States

Location

Dialysis Center, Inc. Kidney Associates of Kansas City

Belton, Missouri, 64012, United States

Location

Dialysis Center of Lincoln

Lincoln, Nebraska, 68510, United States

Location

DaVita Five Star Dialysis Center

Las Vegas, Nevada, 89128, United States

Location

DaVita Inc., South Las Vegas Dialysis

Las Vegas, Nevada, 89169, United States

Location

Dialysis Center, Inc. North Brunswick

North Brunswick, New Jersey, 08902, United States

Location

DaVita Inc., Bronx Dialysis Center

The Bronx, New York, 10461, United States

Location

Dialysis Center, Inc. Philidelphia

Philadelphia, Pennsylvania, 19129, United States

Location

Dialysis Center, Inc. Holston River Clinic

Knoxville, Tennessee, 37924, United States

Location

DaVita Inc., Transmountain Dialysis

El Paso, Texas, 79902, United States

Location

DaVita Inc., Medical Center Dialysis

Houston, Texas, 77004, United States

Location

DaVita Renal Center of Lewisville

Lewisville, Texas, 75057, United States

Location

DaVita Inc., Northwest Medical Center Dialysis

San Antonio, Texas, 78229, United States

Location

DaVita Floyd Curl Dialysis

San Antonio, Texas, 78240, United States

Location

DaVita Inc., Norfolk Dialysis

Chesapeake, Virginia, 23320, United States

Location

Related Publications (1)

• 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.

  PMID: 32843372 RESULT

Related Links

• Related Info

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

Results Point of Contact

• Title: Global CORP Clinical Trials Disclosure
• Organization: Vantive

Global.CORP.ClinicalTrialsDisclosure@vantive.com

+1 2249484283

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: August 18, 2017
• First Posted: August 22, 2017
• Study Start: September 29, 2017
• Primary Completion: October 27, 2018
• Study Completion: October 27, 2018
• Last Updated: July 14, 2025
• Results First Posted: December 19, 2020

Record last verified: 2025-07

Locations

US (20)