Trial Outcomes & Findings for Feasibility Study for Heparin-free Hemodialysis With the Dialyzer With Endexo™ (NCT NCT04511338)

Results Overview

Each participant was expected to receive 3 heparin-free HD sessions. The number and percentage of successful HD sessions were derived based on the 3 heparin-free HD sessions for each participant in each circuit. A successful HD session must meet all the following criteria: 1. Absence of complete HD circuit occlusion (Grade 4) rendering dialysis impossible 2. Absence of the need to replace dialyzers or bloodlines due to clotting 3. Absence of saline flushes to maintain blood flow through the circuit during the HD session 4. Absence of any additional heparin beyond what is allowed per study visits 5. Single pool Kt/V (spKt/V) ≥ 1.2

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

Approximately 5 weeks, Period 1: two weeks with either Circuit A or Circuit B; Washout: 1 week; Period 2: two weeks with the circuit other than Period 1.

Results posted on

2022-03-04

Participant Flow

Participant milestones

Participant milestones
Measure	Sequence AB (Circuit A and Then Circuit B) Circuit (A) includes the dialyzer with Endexo and the CombiSet bloodline Dialyzer with Endexo: Sequence AB: Period 1 Circuit A (Five Visits: 1,2,3,4,5) Period 2 Circuit B (Five Visits: 9,10,11,12,13) Sequence BA: Period 1 Circuit B (Five Visits: 1,2,3,4,5) Period 2 Circuit A (Five Visits: 9,10,11,12,13)	Sequence BA (Circuit B and Then Circuit A) Circuit (A) includes the dialyzer with Endexo and the CombiSet bloodline Dialyzer with Endexo: Sequence AB: Period 1 Circuit A (Five Visits: 1,2,3,4,5) Period 2 Circuit B (Five Visits: 9,10,11,12,13) Sequence BA: Period 1 Circuit B (Five Visits: 1,2,3,4,5) Period 2 Circuit A (Five Visits: 9,10,11,12,13)
Period 1 STARTED	8	8
Period 1 COMPLETED	7	8
Period 1 NOT COMPLETED	1	0
Washout STARTED	8	8
Washout COMPLETED	8	8
Washout NOT COMPLETED	0	0
Period 2 STARTED	8	8
Period 2 COMPLETED	8	5
Period 2 NOT COMPLETED	0	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feasibility Study for Heparin-free Hemodialysis With the Dialyzer With Endexo™

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sequence AB: Circuit A Following by Circuit B n=8 Participants Circuit (A) includes the dialyzer with Endexo and the CombiSet bloodline Dialyzer with Endexo: Sequence AB: Period 1 Circuit A (Five Visits: 1,2,3,4,5) Period 2 Circuit B (Five Visits: 9,10,11,12,13) Sequence BA: Period 1 Circuit B (Five Visits: 1,2,3,4,5) Period 2 Circuit A (Five Visits: 9,10,11,12,13)	Sequence BA: Circuit B Follow by Circuit A n=8 Participants Circuit (B) includes dialyzer with Endexo and the Streamline bloodline Dialyzer with Endexo: Sequence AB: Period 1 Circuit A (Five Visits: 1,2,3,4,5) Period 2 Circuit B (Five Visits: 9,10,11,12,13) Sequence BA: Period 1 Circuit B (Five Visits: 1,2,3,4,5) Period 2 Circuit A (Five Visits: 9,10,11,12,13)	Total n=16 Participants Total of all reporting groups
Age, Continuous	63.6 years STANDARD_DEVIATION 10.16 • n=5 Participants	65.0 years STANDARD_DEVIATION 6.63 • n=7 Participants	64.3 years STANDARD_DEVIATION 8.32 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 5 weeks, Period 1: two weeks with either Circuit A or Circuit B; Washout: 1 week; Period 2: two weeks with the circuit other than Period 1.

Population: Analysis population, defined as subjects who signed the ICF, met inclusion criteria, did not meet any exclusion criteria, were enrolled, randomized, and had at least one heparin reduction HD treatment. Based on the definition of analysis population, there were 15 subjects in Circuit A and 16 subjects in Circuit B.

Each participant was expected to receive 3 heparin-free HD sessions. The number and percentage of successful HD sessions were derived based on the 3 heparin-free HD sessions for each participant in each circuit. A successful HD session must meet all the following criteria: 1. Absence of complete HD circuit occlusion (Grade 4) rendering dialysis impossible 2. Absence of the need to replace dialyzers or bloodlines due to clotting 3. Absence of saline flushes to maintain blood flow through the circuit during the HD session 4. Absence of any additional heparin beyond what is allowed per study visits 5. Single pool Kt/V (spKt/V) ≥ 1.2

Outcome measures

Outcome measures
Measure	Circuit A n=15 Participants Dialyzer with Endexo + CombiSet bloodline	Circuit B n=16 Participants Dialyzer with Endexo + Streamline bloodline
The Primary Endpoint is the Number and Percent (%) of Successful Heparin-free HD Sessions for Each Subject in Each Circuit.	2.4 number of successful HD sessions Standard Deviation 1.12	2.9 number of successful HD sessions Standard Deviation 0.50

SECONDARY outcome

Timeframe: two weeks each period (10 weeks per subject: 4 weeks for screening, 2 weeks for Period 1, 1 week for Washout, and 2 weeks for Period 2)

Population: Safety population, defined as subjects who signed the ICF, met inclusion criteria, did not meet any exclusion criteria, were enrolled, and randomized. Based on the definition of safety population, there were 16 subjects in Circuit A and 16 subjects in Circuit B.

The number of Serious Adverse Events and Adverse Events during the study periods

Outcome measures

Outcome measures
Measure	Circuit A n=16 Participants Dialyzer with Endexo + CombiSet bloodline	Circuit B n=16 Participants Dialyzer with Endexo + Streamline bloodline
The Secondary Endpoints Include Adverse Events .	2 events	4 events

SECONDARY outcome

Timeframe: two weeks each period (10 weeks per subject: 4 weeks for screening, 2 weeks for Period 1, 1 week for Washout, and 2 weeks for Period 2)

Population: Safety population, defined as subjects who signed the ICF, met inclusion criteria, did not meet any exclusion criteria, were enrolled, and randomized. Based on the definition of safety population, there were 16 subjects in Circuit A and 16 subjects in Circuit B.

All device-related serious adverse events and adverse events occurred during the study periods

Outcome measures

Outcome measures
Measure	Circuit A n=16 Participants Dialyzer with Endexo + CombiSet bloodline	Circuit B n=16 Participants Dialyzer with Endexo + Streamline bloodline
The Secondary Endpoints Include Device-related Adverse Events.	0 events	0 events

OTHER_PRE_SPECIFIED outcome

Timeframe: Approximately 5 weeks

Number and percentage of dialyzers (arterial end cap, venous end cap) and blood lines (CombiSet: Arterial chamber, venous chamber; Streamline: Arterial pod, venous pod, venous chamber) for each clotting grade using the visual inspection clotting grade scale

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Approximately 4.5 hours

HD treatment duration or time to complete circuit occlusion (Grade 4). The treatment duration was recorded for each HD session.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Approximately 4.5 hours for each HD session

Population: Analysis population, defined as subjects who signed the ICF, met inclusion criteria, did not meet any exclusion criteria, were enrolled, randomized, and had at least one heparin reduction HD treatment. Based on the definition of analysis population, there were 15 subjects in Circuit A and 16 subjects in Circuit B.

Blood volume processed (BVP) for each of 3 heparin free HD sessions (expected). The average of BVPs for each subject was calculated first then the descriptive stat. were derived.

Outcome measures

Outcome measures
Measure	Circuit A n=15 Participants Dialyzer with Endexo + CombiSet bloodline	Circuit B n=16 Participants Dialyzer with Endexo + Streamline bloodline
Blood Volume Processed for Heparin Free	88.33 L Standard Deviation 7.637	92.37 L Standard Deviation 7.190

Adverse Events

Circuit A

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Circuit B

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Circuit A n=16 participants at risk Dialyzer with Endexo + CombiSet bloodline	Circuit B n=16 participants at risk Dialyzer with Endexo + Streamline bloodline
Gastrointestinal disorders Diarrhoea	0.00% 0/16 • Approximately 2 weeks for each period (10 weeks per subject: 4 weeks for screening period, 2 weeks for Period 1, 1 week for Washout, 2 weeks for Period 2)	6.2% 1/16 • Number of events 1 • Approximately 2 weeks for each period (10 weeks per subject: 4 weeks for screening period, 2 weeks for Period 1, 1 week for Washout, 2 weeks for Period 2)
General disorders Chest pain	6.2% 1/16 • Number of events 1 • Approximately 2 weeks for each period (10 weeks per subject: 4 weeks for screening period, 2 weeks for Period 1, 1 week for Washout, 2 weeks for Period 2)	0.00% 0/16 • Approximately 2 weeks for each period (10 weeks per subject: 4 weeks for screening period, 2 weeks for Period 1, 1 week for Washout, 2 weeks for Period 2)
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/16 • Approximately 2 weeks for each period (10 weeks per subject: 4 weeks for screening period, 2 weeks for Period 1, 1 week for Washout, 2 weeks for Period 2)	6.2% 1/16 • Number of events 1 • Approximately 2 weeks for each period (10 weeks per subject: 4 weeks for screening period, 2 weeks for Period 1, 1 week for Washout, 2 weeks for Period 2)
Metabolism and nutrition disorders Fluid overload	0.00% 0/16 • Approximately 2 weeks for each period (10 weeks per subject: 4 weeks for screening period, 2 weeks for Period 1, 1 week for Washout, 2 weeks for Period 2)	6.2% 1/16 • Number of events 1 • Approximately 2 weeks for each period (10 weeks per subject: 4 weeks for screening period, 2 weeks for Period 1, 1 week for Washout, 2 weeks for Period 2)
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/16 • Approximately 2 weeks for each period (10 weeks per subject: 4 weeks for screening period, 2 weeks for Period 1, 1 week for Washout, 2 weeks for Period 2)	6.2% 1/16 • Number of events 1 • Approximately 2 weeks for each period (10 weeks per subject: 4 weeks for screening period, 2 weeks for Period 1, 1 week for Washout, 2 weeks for Period 2)
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.2% 1/16 • Number of events 1 • Approximately 2 weeks for each period (10 weeks per subject: 4 weeks for screening period, 2 weeks for Period 1, 1 week for Washout, 2 weeks for Period 2)	0.00% 0/16 • Approximately 2 weeks for each period (10 weeks per subject: 4 weeks for screening period, 2 weeks for Period 1, 1 week for Washout, 2 weeks for Period 2)

Additional Information

Senior Director of Statistics and Data Management

Fresenius Medical Care North America

Phone: 1-781-249-8216

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER