Trial Outcomes & Findings for Clinical Study to Assess the Performance of the Dialyzer With Endexo™ (NCT NCT03536663)

Last Updated: 2020-11-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

23 participants

Primary outcome timeframe

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

Results posted on

2020-11-27

Participant Flow

Hemodialysis patients were recruited at three clinical sites in the USA. 23 subjects were enrolled to this study. The first subject first visit was on August 29, 2018 and the last subject last visit was on April 17, 2019.

Participant milestones

Participant milestones
Measure	Optiflux/Endexo Hemodialysis treatments on the dialyzer with Endexo starts at visit 13 and continues until visit 50. Dialysis is performed 3 times per week which means the total of the intervention is approximately 12 weeks. Dialyzer with Endexo: Hemodialysis treatments on the dialyzer with Endexo starts at visit 13 and continues until visit 50. Dialysis is performed 3 times per week which means the total of the intervention is approximately 12 weeks.
Optiflux STARTED	23
Optiflux COMPLETED	19
Optiflux NOT COMPLETED	4
Endexo STARTED	18
Endexo COMPLETED	17
Endexo NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Optiflux/Endexo Hemodialysis treatments on the dialyzer with Endexo starts at visit 13 and continues until visit 50. Dialysis is performed 3 times per week which means the total of the intervention is approximately 12 weeks. Dialyzer with Endexo: Hemodialysis treatments on the dialyzer with Endexo starts at visit 13 and continues until visit 50. Dialysis is performed 3 times per week which means the total of the intervention is approximately 12 weeks.
Endexo Protocol Violation	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Endexo n=18 Participants Hemodialysis treatments on the dialyzer with Endexo starts at visit 13 and continues until visit 50. Dialysis is performed 3 times per week which means the total of the intervention is approximately 13 weeks. Dialyzer with Endexo: Hemodialysis treatments on the dialyzer with Endexo starts at visit 13 and continues until visit 50. Dialysis is performed 3 times per week which means the total of the intervention is approximately 13 weeks.
Age, Continuous	60.28 years STANDARD_DEVIATION 14.23 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants

PRIMARY outcome

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

Population: Subjects who are in the safety population, and have a minimum of 36 HD treatments with the dialyzer with Endexo.

Outcome measures

Outcome measures
Measure	Endexo n=17 Participants Hemodialysis treatments on the dialyzer with Endexo starts at visit 13 and continues until visit 50. Dialysis is performed 3 times per week which means the total of the intervention will be 13 weeks. Dialyzer with Endexo: Hemodialysis treatments on the dialyzer with Endexo starts at visit 13 and continues until visit 50. Dialysis is performed 3 times per week which means the total of the intervention will be 13 weeks.	Endexo Dialyzer with Endexo: Hemodialysis treatments on the dialyzer with Endexo starts at visit 13 and continues until visit 50.
Performance of the Dialyzer With Endexo by Measuring Its in Vivo Ultrafiltration Coefficient	16.36 mL/hr/mmHg Standard Deviation 9.92	—

SECONDARY outcome

Timeframe: 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.

Population: Subjects who sign the ICF, are eligible, are enrolled in the study for Optiflux, and have at least one HD treatment with Endexo dialyzer for Endexo.

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.

Outcome measures

Outcome measures
Measure	Endexo n=23 Participants Hemodialysis treatments on the dialyzer with Endexo starts at visit 13 and continues until visit 50. Dialysis is performed 3 times per week which means the total of the intervention will be 13 weeks. Dialyzer with Endexo: Hemodialysis treatments on the dialyzer with Endexo starts at visit 13 and continues until visit 50. Dialysis is performed 3 times per week which means the total of the intervention will be 13 weeks.	Endexo n=18 Participants Dialyzer with Endexo: Hemodialysis treatments on the dialyzer with Endexo starts at visit 13 and continues until visit 50.
The Number of Any Adverse Events	7 events	32 events

SECONDARY outcome

Timeframe: 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.

Population: Subjects who sign the ICF, are eligible, are enrolled in the study for Optiflux, and have at least one HD treatment with Endexo dialyzer for Endexo.

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.

Outcome measures

Outcome measures
Measure	Endexo n=23 Participants Hemodialysis treatments on the dialyzer with Endexo starts at visit 13 and continues until visit 50. Dialysis is performed 3 times per week which means the total of the intervention will be 13 weeks. Dialyzer with Endexo: Hemodialysis treatments on the dialyzer with Endexo starts at visit 13 and continues until visit 50. Dialysis is performed 3 times per week which means the total of the intervention will be 13 weeks.	Endexo n=18 Participants Dialyzer with Endexo: Hemodialysis treatments on the dialyzer with Endexo starts at visit 13 and continues until visit 50.
The Number of Any Device-related Adverse Events	0 participants, events	0 participants, events

SECONDARY outcome

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

Population: Subjects who are in the safety population, and have a minimum of 36 HD treatments with the dialyzer with Endexo.

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.

Outcome measures

Outcome measures
Measure	Endexo n=17 Participants Hemodialysis treatments on the dialyzer with Endexo starts at visit 13 and continues until visit 50. Dialysis is performed 3 times per week which means the total of the intervention will be 13 weeks. Dialyzer with Endexo: Hemodialysis treatments on the dialyzer with Endexo starts at visit 13 and continues until visit 50. Dialysis is performed 3 times per week which means the total of the intervention will be 13 weeks.	Endexo n=17 Participants Dialyzer with Endexo: Hemodialysis treatments on the dialyzer with Endexo starts at visit 13 and continues until visit 50.
Removal of Urea	80.81 percentage Standard Deviation 4.33	81.87 percentage Standard Deviation 5.91

SECONDARY outcome

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

Population: Subjects who are in the safety population, and have a minimum of 36 HD treatments with the dialyzer with Endexo.

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

Outcome measures

Outcome measures
Measure	Endexo n=17 Participants Hemodialysis treatments on the dialyzer with Endexo starts at visit 13 and continues until visit 50. Dialysis is performed 3 times per week which means the total of the intervention will be 13 weeks. Dialyzer with Endexo: Hemodialysis treatments on the dialyzer with Endexo starts at visit 13 and continues until visit 50. Dialysis is performed 3 times per week which means the total of the intervention will be 13 weeks.	Endexo n=17 Participants Dialyzer with Endexo: Hemodialysis treatments on the dialyzer with Endexo starts at visit 13 and continues until visit 50.
Removal of Albumin	7.89 percent change Standard Deviation 8.63	7.99 percent change Standard Deviation 7.25

SECONDARY outcome

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

Population: Subjects who are in the safety population, and have a minimum of 36 HD treatments with the dialyzer with Endexo. One subject in this pop did not have lab results for pre- and post beta-2-microglobulin in Endexo period. Therefore n=16 instead of 17.

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

Outcome measures

Outcome measures
Measure	Endexo n=17 Participants Hemodialysis treatments on the dialyzer with Endexo starts at visit 13 and continues until visit 50. Dialysis is performed 3 times per week which means the total of the intervention will be 13 weeks. Dialyzer with Endexo: Hemodialysis treatments on the dialyzer with Endexo starts at visit 13 and continues until visit 50. Dialysis is performed 3 times per week which means the total of the intervention will be 13 weeks.	Endexo n=16 Participants Dialyzer with Endexo: Hemodialysis treatments on the dialyzer with Endexo starts at visit 13 and continues until visit 50.
Removal of Beta-2-microglobulin	46.86 percent reduction, corrected Standard Deviation 7.16	67.73 percent reduction, corrected Standard Deviation 16.32

OTHER_PRE_SPECIFIED outcome

Timeframe: 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)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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)

Outcome measures

Outcome data not reported

Adverse Events

Optiflux

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Endexo

Serious events: 3 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Optiflux n=23 participants at risk Hemodialysis treatments on Optiflux dialyzer starts at visit 1 and continues for 4 weeks to visit 12. Dialysis is performed 3 times per week which means the total of the intervention will be 13 weeks.	Endexo n=18 participants at risk Hemodialysis treatments on the dialyzer with Endexo starts at visit 13 and continues until visit 50. Dialysis is performed 3 times per week which means the total of the intervention will be 13 weeks.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/23 • a max of 22 weeks for a subject to complete the study	5.6% 1/18 • Number of events 1 • a max of 22 weeks for a subject to complete the study
Infections and infestations Localised infection	0.00% 0/23 • a max of 22 weeks for a subject to complete the study	5.6% 1/18 • Number of events 1 • a max of 22 weeks for a subject to complete the study
Vascular disorders Hypertensive emergency	0.00% 0/23 • a max of 22 weeks for a subject to complete the study	5.6% 1/18 • Number of events 1 • a max of 22 weeks for a subject to complete the study

Other adverse events

Additional Information

Senior Director of Statistics and Data Management

Fresenius Medical Care North America

Phone: 781-699-4203

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Optiflux n=23 participants at risk Hemodialysis treatments on Optiflux dialyzer starts at visit 1 and continues for 4 weeks to visit 12. Dialysis is performed 3 times per week which means the total of the intervention will be 13 weeks.	Endexo n=18 participants at risk Hemodialysis treatments on the dialyzer with Endexo starts at visit 13 and continues until visit 50. Dialysis is performed 3 times per week which means the total of the intervention will be 13 weeks.
Gastrointestinal disorders Vomiting	0.00% 0/23 • a max of 22 weeks for a subject to complete the study	11.1% 2/18 • Number of events 2 • a max of 22 weeks for a subject to complete the study
Eye disorders Orbital oedema	0.00% 0/23 • a max of 22 weeks for a subject to complete the study	5.6% 1/18 • Number of events 1 • a max of 22 weeks for a subject to complete the study
Gastrointestinal disorders Abdominal discomfort	4.3% 1/23 • Number of events 1 • a max of 22 weeks for a subject to complete the study	0.00% 0/18 • a max of 22 weeks for a subject to complete the study
Gastrointestinal disorders Abdominal pain upper	4.3% 1/23 • Number of events 1 • a max of 22 weeks for a subject to complete the study	0.00% 0/18 • a max of 22 weeks for a subject to complete the study
Gastrointestinal disorders Bowel movement irregularity	0.00% 0/23 • a max of 22 weeks for a subject to complete the study	5.6% 1/18 • Number of events 1 • a max of 22 weeks for a subject to complete the study
Gastrointestinal disorders Diarrhoea	0.00% 0/23 • a max of 22 weeks for a subject to complete the study	5.6% 1/18 • Number of events 1 • a max of 22 weeks for a subject to complete the study
Gastrointestinal disorders Dyspepsia	0.00% 0/23 • a max of 22 weeks for a subject to complete the study	5.6% 1/18 • Number of events 1 • a max of 22 weeks for a subject to complete the study
Gastrointestinal disorders Melaena	0.00% 0/23 • a max of 22 weeks for a subject to complete the study	5.6% 1/18 • Number of events 1 • a max of 22 weeks for a subject to complete the study
General disorders Asthenia	0.00% 0/23 • a max of 22 weeks for a subject to complete the study	11.1% 2/18 • Number of events 2 • a max of 22 weeks for a subject to complete the study
General disorders Tissue infiltration	4.3% 1/23 • Number of events 1 • a max of 22 weeks for a subject to complete the study	5.6% 1/18 • Number of events 1 • a max of 22 weeks for a subject to complete the study
Infections and infestations Influenza	0.00% 0/23 • a max of 22 weeks for a subject to complete the study	5.6% 1/18 • Number of events 1 • a max of 22 weeks for a subject to complete the study
Infections and infestations Nasopharyngitis	0.00% 0/23 • a max of 22 weeks for a subject to complete the study	5.6% 1/18 • Number of events 1 • a max of 22 weeks for a subject to complete the study
Infections and infestations Upper respiratory tract infection	0.00% 0/23 • a max of 22 weeks for a subject to complete the study	5.6% 1/18 • Number of events 1 • a max of 22 weeks for a subject to complete the study
Injury, poisoning and procedural complications Contusion	4.3% 1/23 • Number of events 1 • a max of 22 weeks for a subject to complete the study	0.00% 0/18 • a max of 22 weeks for a subject to complete the study
Injury, poisoning and procedural complications Vascular access site pain	4.3% 1/23 • Number of events 1 • a max of 22 weeks for a subject to complete the study	0.00% 0/18 • a max of 22 weeks for a subject to complete the study
Injury, poisoning and procedural complications Vascular access site thrombosis	0.00% 0/23 • a max of 22 weeks for a subject to complete the study	5.6% 1/18 • Number of events 1 • a max of 22 weeks for a subject to complete the study
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/23 • a max of 22 weeks for a subject to complete the study	5.6% 1/18 • Number of events 1 • a max of 22 weeks for a subject to complete the study
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/23 • a max of 22 weeks for a subject to complete the study	5.6% 1/18 • Number of events 1 • a max of 22 weeks for a subject to complete the study
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/23 • a max of 22 weeks for a subject to complete the study	5.6% 1/18 • Number of events 1 • a max of 22 weeks for a subject to complete the study
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/23 • a max of 22 weeks for a subject to complete the study	11.1% 2/18 • Number of events 2 • a max of 22 weeks for a subject to complete the study
Nervous system disorders Headache	0.00% 0/23 • a max of 22 weeks for a subject to complete the study	16.7% 3/18 • Number of events 3 • a max of 22 weeks for a subject to complete the study
Nervous system disorders Hypoaesthesia	0.00% 0/23 • a max of 22 weeks for a subject to complete the study	5.6% 1/18 • Number of events 1 • a max of 22 weeks for a subject to complete the study
Respiratory, thoracic and mediastinal disorders Cough	4.3% 1/23 • Number of events 1 • a max of 22 weeks for a subject to complete the study	5.6% 1/18 • Number of events 1 • a max of 22 weeks for a subject to complete the study
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/23 • a max of 22 weeks for a subject to complete the study	5.6% 1/18 • Number of events 1 • a max of 22 weeks for a subject to complete the study
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.3% 1/23 • Number of events 1 • a max of 22 weeks for a subject to complete the study	0.00% 0/18 • a max of 22 weeks for a subject to complete the study
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/23 • a max of 22 weeks for a subject to complete the study	5.6% 1/18 • Number of events 1 • a max of 22 weeks for a subject to complete the study
Vascular disorders Hypertension	0.00% 0/23 • a max of 22 weeks for a subject to complete the study	5.6% 1/18 • Number of events 1 • a max of 22 weeks for a subject to complete the study
Vascular disorders Hypotension	0.00% 0/23 • a max of 22 weeks for a subject to complete the study	11.1% 2/18 • Number of events 2 • a max of 22 weeks for a subject to complete the study