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

Primary Purpose

Kidney Failure, Chronic

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Optiflux and Dialyzer with Endexo

About this trial

This is an interventional treatment trial for Kidney Failure, Chronic

Eligibility Criteria

22 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Balboa Nephrology Med Group
California Institute of Renal Research
Research Management Inc/ Kansas Nephrology Research Institute, LLC-J/V

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Optiflux/Endexo

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Removal of Albumin

%change = (post-HD - pre-HD)/pre-HD * 100

Removal of Beta-2-microglobulin

% reduction = (post-HD - pre-HD)/pre-HD * 100 with post-HD B2M adjusted to pre- and post HD weights

Full Information

NCT ID

NCT03536663

First Posted

April 6, 2018

Last Updated

November 13, 2020

Sponsor

Fresenius Medical Care North America

1. Study Identification

Unique Protocol Identification Number

NCT03536663

Brief Title

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

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

August 29, 2018 (Actual)

Primary Completion Date

April 17, 2019 (Actual)

Study Completion Date

June 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fresenius Medical Care North America

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Failure, Chronic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Optiflux/Endexo

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

Optiflux and Dialyzer with Endexo

Intervention Description

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 Measure Information:

Title

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

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

The Number of Any Adverse Events

Description

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.

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.

Title

The Number of Any Device-related Adverse Events

Description

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.

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.

Title

Removal of Urea

Description

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.

Time Frame

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

Title

Removal of Albumin

Description

%change = (post-HD - pre-HD)/pre-HD * 100

Time Frame

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

Title

Removal of Beta-2-microglobulin

Description

% reduction = (post-HD - pre-HD)/pre-HD * 100 with post-HD B2M adjusted to pre- and post HD weights

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Dialyzer Hemocompatibility

Description

The dialyzer hemo-compatibility is measured by measuring the activation of the complement system (C3a, C5a, SC5b-9)

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

Title

Clotting of the Dialyzer

Description

Thrombus scoring will be assessed according to a clotting scale (The graded scoring method)

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shakil Aslam, MD

Organizational Affiliation

Fresenius Medical Care RTG, LLC

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Dylan Steer, MD

Organizational Affiliation

California Institute of Renal Research

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Lisa Weber, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jill Meyer, MD

Organizational Affiliation

Balboa Nephrology Med Group

Official's Role

Principal Investigator

Facility Information:

Facility Name

Balboa Nephrology Med Group

City

Chula Vista

State/Province

California

ZIP/Postal Code

92154

Country

United States

Facility Name

California Institute of Renal Research

City

San Diego

State/Province

California

ZIP/Postal Code

92111

Country

United States

Facility Name

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

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67214

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

33789265

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.

Results Reference

derived

Learn more about this trial

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

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