Clinical Study to Assess the Performance of the Dialyzer With Endexo™

NCT03536663 | Completed Results DMC FDA Device

• 1 other identifier: Endexo-001
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 3

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."

Conditions

Kidney Failure, Chronic

Outcome Measures

Primary Outcomes (1)

• Performance of the Dialyzer With Endexo by Measuring Its in Vivo Ultrafiltration Coefficient

  Ultrafiltration coefficient (Kuf) is the ratio of ultrafiltration rate in ml/hr to the Transmembrane pressure in mmHg. Both the Ultrafiltration rate and the transmembrane pressure readings are collected from the machine.

  15 minutes after the recorded start of hemodialysis with Endexo upon its first use in the study

Secondary Outcomes (5)

• The Number of Any Adverse Events

  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.

• The Number of Any Device-related Adverse Events

  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.

• Removal of Urea

  At visits 1/week 1, 10/week 4, 13/week 5, 22/week 8, 34/week 12, and 46/week 16

• Removal of Albumin

  Pre- and Post- HD at Visits 1/week 1, 13/week 5

• Removal of Beta-2-microglobulin

  Pre- and Post- HD at Visits 1/week 1, 13/week 5

Other Outcomes (2)

• Dialyzer Hemocompatibility

  Assessed at the first time the dialyzers are used in the study , collected pre hemodialysis and 30 minutes after the recorded start of hemodialysis

• Clotting of the Dialyzer

  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.

Study Arms (1)

Optiflux/Endexo

OTHER

Optiflux (Active Comparator); Hemodialysis treatments on the Optiflux dialyzer (Optiflux Period) for 4 weeks - Visit 1 to 12 Endexo (Experimental); Subjects continue on Dialyzer with Endexo (Endexo Period) for 13 weeks - Visit 13 to visit 50

Device: Optiflux and Dialyzer with Endexo

Interventions

Optiflux and Dialyzer with Endexo DEVICE

Hemodialysis (HD) on Optiflux dialyzer from Visit 1 to 12 and followed by HD on the dialyzer with Endexo at visit 13 and continues until visit 50. Dialysis is performed 3 times per week which means the total of the intervention will be 17 weeks.

Optiflux/Endexo

Eligibility Criteria

• Age: 22 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be an adult, older than 22 years of age.
• Has been prescribed in-center thrice-weekly HD continuously for at least 180 days prior to the date of signed informed consent
• Has been prescribed the Optiflux F160NR dialyzer continuously for at least 30 days prior to the date of signed informed consent
• Has a prescribed HD treatment time ≥180 minutes (3 hours) and ≤270 minutes (4.5 hours)
• 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
• Has a most recent single pool Kt/V (spKt/V) ≥1.2 within 45 days prior to the date of a signed informed consent
• Has a most recent hemoglobin ≥9 g/dL within 45 days prior to the date of a signed informed consent
• Has a most recent platelet count ≥100,000/mm3 within 45 days prior to the date of a signed informed consent
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fresenius Medical Care North America: lead

Study Sites (3)

Balboa Nephrology Med Group

Chula Vista, California, 92154, United States

Location

California Institute of Renal Research

San Diego, California, 92111, United States

Location

Research Management Inc/ Kansas Nephrology Research Institute, LLC-J/V

Wichita, Kansas, 67214, United States

Location

Related Publications (1)

• 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.

  PMID: 33789265 DERIVED

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: Senior Director of Statistics and Data Management
• Organization: Fresenius Medical Care North America

ChiangHong.Ho@fmc-na.com

781-699-4203

Study Officials

• Shakil Aslam, MD

  Fresenius Medical Care RTG, LLC

  STUDY DIRECTOR

• Dylan Steer, MD

  California Institute of Renal Research

  PRINCIPAL INVESTIGATOR

• Lisa Weber, MD

  Research Management Inc/ Kansas Nephrology Research Institute, LLC-J/V

  PRINCIPAL INVESTIGATOR

• Jill Meyer, MD

  Balboa Nephrology Med Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

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

Model Details: 12 HD treatments (4 weeks) with Optiflux dialyzer followed by 38 HD treatments (13 weeks) with Endexo dialyzer

Study Record Dates

• First Submitted: April 6, 2018
• First Posted: May 25, 2018
• Study Start: August 29, 2018
• Primary Completion: April 17, 2019
• Study Completion: June 17, 2019
• Last Updated: November 27, 2020
• Results First Posted: November 12, 2020

Record last verified: 2020-11

Locations

US (3)