Clinical trial NCT03536663: Clinical Study to Assess the Performance of the Dialyzer With Endexo™
Official title: An Open-Label Clinical Study to Assess the Performance of the Dialyzer With Endexo™ in End-Stage Renal Disease Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Failure, Chronic
Lead sponsor: Fresenius Medical Care North America
Sponsor class: INDUSTRY
First posted: 2018-05-25
Enrollment: 23
Sex: ALL
Minimum age (years): 22
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: 12 HD treatments (4 weeks) with Optiflux dialyzer followed by 38 HD treatments (13 weeks) with Endexo dialyzer
Primary purpose: TREATMENT

Brief summary: Endexo™ is an additive that is blended into the fiber solution during manufacturing of the hemodialyzer hollow fibers. The intended purpose of the additive is to increase blood compatibility in the finished dialyzer, which is referred to as the "dialyzer with Endexo."

Detailed description: This is a prospective, sequential, multi-center, open-label study with subjects on thrice-weekly (in-center) hemodialysis (HD). After a Screening Period, there will be 12 hemodialysis treatments on the Optiflux dialyzer (Optiflux Period), followed by 38 HD treatments on the dialyzer with Endexo (Endexo Period), and then a Follow-up Visit. The study population will consist of End-Stage Renal Disease ESRD subjects who are a minimum of 22 years of age. The primary objective of the study is to collect data on the performance of the dialyzer with Endexo when used to perform hemodialysis (HD) in End-Stage Renal Disease (ESRD) subjects.

Eligibility criteria: Inclusion Criteria:

1. Must be an adult, older than 22 years of age.
2. Has been prescribed in-center thrice-weekly HD continuously for at least 180 days prior to the date of signed informed consent
3. Has been prescribed the Optiflux F160NR dialyzer continuously for at least 30 days prior to the date of signed informed consent
4. Has a prescribed HD treatment time ≥180 minutes (3 hours) and ≤270 minutes (4.5 hours)
5. Has been on heparin anticoagulation for dialysis and has had no change in heparin prescription within 14 days prior to the date of signed informed consent
6. Has a most recent single pool Kt/V (spKt/V) ≥1.2 within 45 days prior to the date of a signed informed consent
7. Has a most recent hemoglobin ≥9 g/dL within 45 days prior to the date of a signed informed consent
8. Has a most recent platelet count ≥100,000/mm3 within 45 days prior to the date of a signed informed consent
9. A female of childbearing potential must have a negative serum pregnancy test at the time of screening and agree to use an acceptable method of contraception during the study

Exclusion Criteria:

1. Use of citric acid concentrate (such as Citrasate®) at the time of signed informed consent
2. Known allergic reactions to Endexo
3. Hospitalization within 30 days prior to the date of signed informed consent
4. Presence of active malignancy, congestive heart failure New York Heart Association (NYHA) Class III or IV, or liver cirrhosis
5. Are receiving or have received chemotherapy / radiation therapy / plasmapheresis therapy within 90 days prior to the date of signed informed consent
6. Are receiving antibiotics or have used antibiotics within 14 days prior to the date of signed informed consent
7. Are currently enrolled in or have completed any other investigational product study within 30 days prior to the date of signed informed consent
8. Has a life expectancy of less than 1 year

Primary outcomes:
measure: Performance of the Dialyzer With Endexo by Measuring Its in Vivo Ultrafiltration Coefficient
timeFrame: 15 minutes after the recorded start of hemodialysis with Endexo upon its first use in the study
Secondary outcomes:
measure: The Number of Any Adverse Events
timeFrame: Optiflux: from enrollment, weeks 1 to 4 (visits 1 to 12); Endexo: from weeks 5 to 17, and follow-up, a total of 17 weeks intervention.
measure: The Number of Any Device-related Adverse Events
timeFrame: Optiflux: from enrollment, weeks 1 to 4 (visits 1 to 12); Endexo: from weeks 5 to 17, and follow-up, a total of 17 weeks intervention.
measure: Removal of Urea
timeFrame: At visits 1/week 1, 10/week 4, 13/week 5, 22/week 8, 34/week 12, and 46/week 16
measure: Removal of Albumin
timeFrame: Pre- and Post- HD at Visits 1/week 1, 13/week 5
measure: Removal of Beta-2-microglobulin
timeFrame: Pre- and Post- HD at Visits 1/week 1, 13/week 5
Other outcomes:
measure: Dialyzer Hemocompatibility
timeFrame: Assessed at the first time the dialyzers are used in the study , collected pre hemodialysis and 30 minutes after the recorded start of hemodialysis
measure: Clotting of the Dialyzer
timeFrame: visual evaluation of the dialyzer arterial cap will be performed at the end of every hemodialysis treatment to determine the Grade:1,2,3 or 4. (1:no clotting to 4: total clotting), throughout a total of 17 weeks intervention.
Locations:
city: Chula Vista
country: United States
facility: Balboa Nephrology Med Group
state: California
city: San Diego
country: United States
facility: California Institute of Renal Research
state: California
city: Wichita
country: United States
facility: Research Management Inc/ Kansas Nephrology Research Institute, LLC-J/V
state: Kansas
Study officials:
affiliation: Fresenius Medical Care RTG, LLC
name: Shakil Aslam, MD
role: STUDY_DIRECTOR
affiliation: California Institute of Renal Research
name: Dylan Steer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Management Inc/ Kansas Nephrology Research Institute, LLC-J/V
name: Lisa Weber, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Balboa Nephrology Med Group
name: Jill Meyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meyer JM, Steer D, Weber LA, Zeitone AA, Thakuria M, Ho CH, Aslam S, Mullon C, Kossmann RJ. Safety of a Novel Dialyzer Containing a Fluorinated Polyurethane Surface-Modifying Macromolecule in Patients with End-Stage Kidney Disease. Blood Purif. 2021;50(6):959-967. doi: 10.1159/000514937. Epub 2021 Mar 31.