Trial Outcomes & Findings for Molecule Removal and Ease of Use: A Comparison of Two Different Dialyzers (NCT NCT00636389)

Results Overview

Urea removal is correlated with successful clinical outcomes. Kt/V is a way of measuring the delivered dose of dialysis where K=clearance of urea, t=treatment time and V=volume of body water. Single-pool (sp) Kt/V assumes that urea is removed from a single compartment in the human body during dialysis. However, because there are multiple compartments in the human body, rebound occurs following hemodialysis which lowers the Kt/V. Equilibrated (e) Kt/V is an equation that has been devised to predict the amount of rebound based on the ratio of K/V. Outcomes are posted for both spKt/V and eKt/V.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments

Results posted on

2025-07-14

Participant Flow

Participant milestones

Participant milestones
Measure	HD-C4 First (Period 1), Then 210H (Period 2) Subjects were randomly assigned to begin the first week (Period 1) of three consecutive treatments with the Polyflux HD-C4 dialyzer. Following the third treatment, the subjects were switched to the Polyflux 210H dialyzer for a second week (Period 2) of three consecutive treatments. Therefore each subject had a total of six consecutive dialysis treatments.	210H First (Period 1), Then HD-C4 (Period 2) Subjects were randomly assigned to begin the first week (Period 1)of three consecutive treatments with the Polyflux 210H dialyzer. Following the third treatment, the subjects were switched to the Polyflux HD-C4 dialyzer for a second week (Period 2) of three consecutive treatments. Therefore each subject had a total of six consecutive dialysis treatments.
Period 1 - 1 Week STARTED	7	5
Period 1 - 1 Week COMPLETED	7	5
Period 1 - 1 Week NOT COMPLETED	0	0
Period 2 - 1 Week STARTED	7	5
Period 2 - 1 Week COMPLETED	7	5
Period 2 - 1 Week NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Molecule Removal and Ease of Use: A Comparison of Two Different Dialyzers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=12 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	50.2 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments

Urea removal is correlated with successful clinical outcomes. Kt/V is a way of measuring the delivered dose of dialysis where K=clearance of urea, t=treatment time and V=volume of body water. Single-pool (sp) Kt/V assumes that urea is removed from a single compartment in the human body during dialysis. However, because there are multiple compartments in the human body, rebound occurs following hemodialysis which lowers the Kt/V. Equilibrated (e) Kt/V is an equation that has been devised to predict the amount of rebound based on the ratio of K/V. Outcomes are posted for both spKt/V and eKt/V.

Outcome measures

Outcome measures
Measure	HD-C4 n=12 Participants	210H n=12 Participants
Comparison of Urea Removal Under Conditions of Routine Hemodialysis. Single-pool Kt/V Urea	1.64 ratio Standard Deviation 0.26	1.61 ratio Standard Deviation 0.24
Comparison of Urea Removal Under Conditions of Routine Hemodialysis. Equilibrated Kt/V	1.42 ratio Standard Deviation 0.22	1.40 ratio Standard Deviation 0.22

PRIMARY outcome

Timeframe: 2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments

Overall removal of urea, phosphorus and β2-microglobulin was determined from the pre- to post-dialysis change in plasma concentration and from the amount of solute recovered in the dialysate. This outcome measure is reported as the percentage of pre- to post-dialysis reduction of urea, phosphorus and β2-microglobulin.

Outcome measures

Outcome measures
Measure	HD-C4 n=12 Participants	210H n=12 Participants
A Comparison of Pre- to Post-dialysis Reduction of Small and Large Molecules Under Conditions of Routine Hemodialysis. Urea Pre- to post-dialysis reduction (%)	74 Percentage of reduction Standard Deviation 6	74 Percentage of reduction Standard Deviation 5
A Comparison of Pre- to Post-dialysis Reduction of Small and Large Molecules Under Conditions of Routine Hemodialysis. Phosphorus Pre- to post-dialysis reduction (%)	61 Percentage of reduction Standard Deviation 9	60 Percentage of reduction Standard Deviation 17
A Comparison of Pre- to Post-dialysis Reduction of Small and Large Molecules Under Conditions of Routine Hemodialysis. b2-microglobulin Pre- to post-dialysis reduct (%)	52 Percentage of reduction Standard Deviation 12	58 Percentage of reduction Standard Deviation 8

SECONDARY outcome

Timeframe: 2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments

Population: Each of the 12 subjects underwent three consecutive treatments with the HD-C4 and three consecutive treatments with the Polyflux 210H.

Assessment of blood side priming: 1=Very Easy 2=Acceptable 3=Difficult 4=Very Difficult / Assessment of dialysate side priming: 1=Perfect 2=Acceptable 3= Not Acceptable / Appearance of dialyzer fibers: 1=Very Good 2=Good 3=Poor 4=Very Poor / Appearance of dialyzer arterial header: 1=Very Good 2=Good 3=Poor 4=Very Poor / Appearance of venous header: 1=Very Good 2=Good 3=Poor 4=Very Poor /

Outcome measures

Outcome measures
Measure	HD-C4 n=36 dialyzers	210H n=36 dialyzers
Comparison of Dialyzer Ease of Use Between the Polyflux HD-C4 Dialyzer and the Polyflux 210H Priming of blood compartment	1.19 Units on a Scale 1 = Best Standard Deviation 0.40	1.47 Units on a Scale 1 = Best Standard Deviation 0.51
Comparison of Dialyzer Ease of Use Between the Polyflux HD-C4 Dialyzer and the Polyflux 210H Priming of dialysate compartment	1.36 Units on a Scale 1 = Best Standard Deviation 0.49	1.51 Units on a Scale 1 = Best Standard Deviation 0.51
Comparison of Dialyzer Ease of Use Between the Polyflux HD-C4 Dialyzer and the Polyflux 210H Appearance of fibers	1.42 Units on a Scale 1 = Best Standard Deviation 0.55	1.78 Units on a Scale 1 = Best Standard Deviation 0.64
Comparison of Dialyzer Ease of Use Between the Polyflux HD-C4 Dialyzer and the Polyflux 210H Appearance of arterial header	1.61 Units on a Scale 1 = Best Standard Deviation 0.55	1.72 Units on a Scale 1 = Best Standard Deviation 0.51
Comparison of Dialyzer Ease of Use Between the Polyflux HD-C4 Dialyzer and the Polyflux 210H Appearance of venous header	1.57 Units on a Scale 1 = Best Standard Deviation 0.74	1.77 Units on a Scale 1 = Best Standard Deviation 0.55

Adverse Events

HD-C4 First (Period 1), Then 210H (Period 2)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

210H First (Period 1), Then HD-C4 (Period 2)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Global CORP Clinical Trials Disclosure

Vantive

Phone: +1 2249484283

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60