Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    Endexo
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03536663
Recruitment Status : Completed
First Posted : May 25, 2018
Results First Posted : November 12, 2020
Last Update Posted : November 27, 2020
Sponsor:
Information provided by (Responsible Party):
Fresenius Medical Care North America

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."

Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Device: Optiflux and Dialyzer with Endexo Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description: 12 HD treatments (4 weeks) with Optiflux dialyzer followed by 38 HD treatments (13 weeks) with Endexo dialyzer
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Clinical Study to Assess the Performance of the Dialyzer With Endexo™ in End-Stage Renal Disease Subjects
Actual Study Start Date : August 29, 2018
Actual Primary Completion Date : April 17, 2019
Actual Study Completion Date : June 17, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Failure

Arm Intervention/treatment
Optiflux/Endexo
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
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.




Primary Outcome Measures :
  1. Performance of the Dialyzer With Endexo by Measuring Its in Vivo Ultrafiltration Coefficient [ Time Frame: 15 minutes after the recorded start of hemodialysis with Endexo upon its first use in the study ]
    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.


Secondary Outcome Measures :
  1. The Number of Any Adverse Events [ Time Frame: 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. ]
    All adverse events were captured from subject enrollment to the completion of Optiflux period, and to the end of study or withdraws from the study.

  2. The Number of Any Device-related Adverse Events [ Time Frame: 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. ]
    Any device-related adverse events were captured from subject enrollment to the completion of Optiflux period, and to the end of study or withdraws from the study.

  3. Removal of Urea [ Time Frame: At visits 1/week 1, 10/week 4, 13/week 5, 22/week 8, 34/week 12, and 46/week 16 ]
    1. URR = (pre-HD urea - post-HD urea)/pre-HD urea * 100
    2. Data across visits were averaged for each subject, and then a group mean and sd were calculated.

  4. Removal of Albumin [ Time Frame: Pre- and Post- HD at Visits 1/week 1, 13/week 5 ]
    %change = (post-HD - pre-HD)/pre-HD * 100

  5. Removal of Beta-2-microglobulin [ Time Frame: Pre- and Post- HD at Visits 1/week 1, 13/week 5 ]
    % reduction = (post-HD - pre-HD)/pre-HD * 100 with post-HD B2M adjusted to pre- and post HD weights


Other Outcome Measures:
  1. Dialyzer Hemocompatibility [ Time Frame: Assessed at the first time the dialyzers are used in the study , collected pre hemodialysis and 30 minutes after the recorded start of hemodialysis ]
    The dialyzer hemo-compatibility is measured by measuring the activation of the complement system (C3a, C5a, SC5b-9)

  2. Clotting of the Dialyzer [ Time Frame: 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. ]
    Thrombus scoring will be assessed according to a clotting scale (The graded scoring method)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   22 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03536663


Locations
Layout table for location information
United States, California
Balboa Nephrology Med Group
Chula Vista, California, United States, 92154
California Institute of Renal Research
San Diego, California, United States, 92111
United States, Kansas
Research Management Inc/ Kansas Nephrology Research Institute, LLC-J/V
Wichita, Kansas, United States, 67214
Sponsors and Collaborators
Fresenius Medical Care North America
Investigators
Layout table for investigator information
Study Director: Shakil Aslam, MD Fresenius Medical Care RTG, LLC
Principal Investigator: 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
  Study Documents (Full-Text)

Documents provided by Fresenius Medical Care North America:
Statistical Analysis Plan  [PDF] August 5, 2019
Study Protocol  [PDF] October 26, 2018

Layout table for additonal information
Responsible Party: Fresenius Medical Care North America
ClinicalTrials.gov Identifier: NCT03536663    
Other Study ID Numbers: Endexo-001
First Posted: May 25, 2018    Key Record Dates
Results First Posted: November 12, 2020
Last Update Posted: November 27, 2020
Last Verified: November 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic