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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
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Fresenius Medical Care North America

Brief Summary:
EndexoTM 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: 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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 : July 23, 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
Experimental: Endexo
Hemodialysis treatments on the dialyzer with Endexo starts at visit 14 and continues until visit 50. Dialysis is performed 3 times per week which means the total of the intervention will be 13 weeks.
Device: Dialyzer with Endexo
Hemodialysis treatments on the dialyzer with Endexo starts at visit 14 and continues until visit 50. Dialysis is performed 3 times per week which means the total of the intervention will be 13 weeks.




Primary Outcome Measures :
  1. Assess the 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 and device-related adverse events [ Time Frame: Throughout the study duration of 22 weeks ]
    All adverse events and serious adverse events will be captured from the time the subject signs the ICF until the subject completes or withdraws from the study.

  2. Removal of Urea [ Time Frame: Throughout the study duration of 22 weeks ]
    Urea Reduction Ratio (URR)

  3. Removal of Albumin [ Time Frame: pre- hemodialysis and post- hemodialysis throughout the study duration of 22 weeks ]
    Measure blood values of Albumin Pre- and post-hemodialysis

  4. Removal of beta-2-microglobulin [ Time Frame: pre- hemodialysis and post- hemodialysis throughout the study duration of 22 weeks ]
    Measure blood values of beta-2-microglobulin Pre- and post-hemodialysis


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 the study duration of 22 weeks ]
    Thrombus scoring will be assessed according to a clotting scale (The graded scoring method)



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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
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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
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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
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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
Last Update Posted: September 12, 2019
Last Verified: February 2019

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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:
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Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic