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

Vantive Health LLC

Status: Completed

Conditions: End Stage Renal Disease

Treatments: Device: Theranova 400 dialyzer; Device: Elisio-17H dialyzer

Study type: Interventional

Funder types: Industry

Identifiers

NCT03257410

7905001

Details and patient eligibility

About

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.

Enrollment: 172 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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172 participants in 2 patient groups

Theranova 400

Experimental group

Description:

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

Treatment:

Device: Theranova 400 dialyzer

Elisio-17H

Active Comparator group

Description:

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

Treatment:

Device: Elisio-17H dialyzer