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

Kidney Failure, Chronic Clinical Trial

Official title:

An Open-Label Clinical Study to Assess the Performance of the Dialyzer With Endexo™ in End-Stage Renal Disease Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03536663
• Other study ID #: Endexo-001
• Status: Completed
• Phase: N/A
• Start date: August 29, 2018
• Est. completion date: June 17, 2019

Study information

• Verified date: November 2020
• Source: Fresenius Medical Care North America
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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."

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 17, 2019
• Est. primary completion date: April 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

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.

Locations

Country	Name	City	State
United States	Balboa Nephrology Med Group	Chula Vista	California
United States	California Institute of Renal Research	San Diego	California
United States	Research Management Inc/ Kansas Nephrology Research Institute, LLC-J/V	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Medical Care North America

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dialyzer Hemocompatibility	The dialyzer hemo-compatibility is measured by measuring the activation of the complement system (C3a, C5a, SC5b-9)	Assessed at the first time the dialyzers are used in the study , collected pre hemodialysis and 30 minutes after the recorded start of hemodialysis
Other	Clotting of the Dialyzer	Thrombus scoring will be assessed according to a clotting scale (The graded scoring method)	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.
Primary	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	The Number of Any Adverse Events	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.	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.
Secondary	The Number of Any Device-related Adverse Events	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.	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.
Secondary	Removal of Urea	URR = (pre-HD urea - post-HD urea)/pre-HD urea * 100; Data across visits were averaged for each subject, and then a group mean and sd were calculated.	At visits 1/week 1, 10/week 4, 13/week 5, 22/week 8, 34/week 12, and 46/week 16
Secondary	Removal of Albumin	%change = (post-HD - pre-HD)/pre-HD * 100	Pre- and Post- HD at Visits 1/week 1, 13/week 5
Secondary	Removal of Beta-2-microglobulin	% reduction = (post-HD - pre-HD)/pre-HD * 100 with post-HD B2M adjusted to pre- and post HD weights	Pre- and Post- HD at Visits 1/week 1, 13/week 5