Trial Outcomes & Findings for Comparative Effects Of Dialysate Flow Rate And Membrane Packing On The Performance Of Dialyzers Used For Hemodialysis (NCT NCT00636077)
NCT ID: NCT00636077
Last Updated: 2025-07-14
Results Overview
KoA is a constant that describes the efficiency of a dialyzer in removing urea. KoA is determined by surface area of the membrane, the thickness of the membrane and pore size.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
During the third treatment with each dialyzer (one time during each trial period week)
Results posted on
2025-07-14
Participant Flow
Participant milestones
| Measure |
HD-C4 Big First
Patients in this Arm will receive 3 consecutive treatments with the HD-C4 Big dialyzer first. For the study each patient will be treated for three consecutive treatments with each of the 4 study dialyzers (total of 12 consecutive treatments).
|
HD-C4 Small First
Patients in this Arm will receive 3 consecutive treatments with the HD-C4 Small dialyzer first. For the study each patient will be treated for three consecutive treatments with each of the 4 study dialyzers (total of 12 consecutive treatments).
|
Optiflux F160NR First
Patients in this Arm will receive 3 consecutive treatments with the F160NR dialyzer first. For the study each patient will be treated for three consecutive treatments with each of the 4 study dialyzers (total of 12 consecutive treatments).
|
Optiflux F200NR First
Patients in this Arm will receive 3 consecutive treatments with the F200NR dialyzer first. For the study each patient will be treated for three consecutive treatments with each of the 4 study dialyzers (total of 12 consecutive treatments).
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Week 1
STARTED
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3
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3
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3
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3
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Week 1
COMPLETED
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3
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3
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3
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3
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Week 1
NOT COMPLETED
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0
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0
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0
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0
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Week 2
STARTED
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3
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3
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3
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3
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Week 2
COMPLETED
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3
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3
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3
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3
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Week 2
NOT COMPLETED
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0
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0
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0
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0
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Week 3
STARTED
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3
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3
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3
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3
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Week 3
COMPLETED
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3
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3
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3
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3
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Week 3
NOT COMPLETED
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0
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0
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0
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0
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Week 4
STARTED
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3
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3
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3
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3
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Week 4
COMPLETED
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3
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3
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3
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3
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Week 4
NOT COMPLETED
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0
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0
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparative Effects Of Dialysate Flow Rate And Membrane Packing On The Performance Of Dialyzers Used For Hemodialysis
Baseline characteristics by cohort
| Measure |
All Study Participants
n=12 Participants
|
|---|---|
|
Age, Continuous
|
60 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During the third treatment with each dialyzer (one time during each trial period week)KoA is a constant that describes the efficiency of a dialyzer in removing urea. KoA is determined by surface area of the membrane, the thickness of the membrane and pore size.
Outcome measures
| Measure |
HD-C4 Big
n=12 Participants
3 consecutive treatments with the HD-C4 Big dialyzer.
|
HD-C4 Small
n=12 Participants
3 consecutive treatments with the HD-C4 Small dialyzer.
|
F160NR
n=12 Participants
3 consecutive treatments with the F160NR dialyzer.
|
F200NR
n=12 Participants
3 consecutive treatments with the F200NR dialyzer.
|
|---|---|---|---|---|
|
Effect of Increased Dialysate Flow Rate on KoA for Urea Between 4 Dialyzers With Different Membrane Packing Densities.
350 mL/min Dialysate Flow Rate
|
844 KoA for urea (mL/min)
Standard Error 30
|
763 KoA for urea (mL/min)
Standard Error 34
|
770 KoA for urea (mL/min)
Standard Error 36
|
798 KoA for urea (mL/min)
Standard Error 21
|
|
Effect of Increased Dialysate Flow Rate on KoA for Urea Between 4 Dialyzers With Different Membrane Packing Densities.
500 mL/min Dialysate Flow Rate
|
898 KoA for urea (mL/min)
Standard Error 31
|
748 KoA for urea (mL/min)
Standard Error 34
|
738 KoA for urea (mL/min)
Standard Error 40
|
890 KoA for urea (mL/min)
Standard Error 33
|
|
Effect of Increased Dialysate Flow Rate on KoA for Urea Between 4 Dialyzers With Different Membrane Packing Densities.
800 mL/min Dialysate Flow Rate
|
922 KoA for urea (mL/min)
Standard Error 31
|
761 KoA for urea (mL/min)
Standard Error 25
|
809 KoA for urea (mL/min)
Standard Error 24
|
817 KoA for urea (mL/min)
Standard Error 36
|
PRIMARY outcome
Timeframe: During the third treatment with each dialyzer (one time during each trial period week)Outcome measures
| Measure |
HD-C4 Big
n=12 Participants
3 consecutive treatments with the HD-C4 Big dialyzer.
|
HD-C4 Small
n=12 Participants
3 consecutive treatments with the HD-C4 Small dialyzer.
|
F160NR
n=12 Participants
3 consecutive treatments with the F160NR dialyzer.
|
F200NR
n=12 Participants
3 consecutive treatments with the F200NR dialyzer.
|
|---|---|---|---|---|
|
Effect of Increased Dialysate Flow Rate on Whole Blood Urea Clearance Between 4 Dialyzers With Different Membrane Packing Densities.
350 mL/min Dialysate Flow Rate
|
279 Whole blood urea clearance (mL/min)
Standard Error 3
|
270 Whole blood urea clearance (mL/min)
Standard Error 4
|
271 Whole blood urea clearance (mL/min)
Standard Error 4
|
274 Whole blood urea clearance (mL/min)
Standard Error 2
|
|
Effect of Increased Dialysate Flow Rate on Whole Blood Urea Clearance Between 4 Dialyzers With Different Membrane Packing Densities.
500 mL/min Dialysate Flow Rate
|
315 Whole blood urea clearance (mL/min)
Standard Error 3
|
295 Whole blood urea clearance (mL/min)
Standard Error 5
|
293 Whole blood urea clearance (mL/min)
Standard Error 8
|
313 Whole blood urea clearance (mL/min)
Standard Error 4
|
|
Effect of Increased Dialysate Flow Rate on Whole Blood Urea Clearance Between 4 Dialyzers With Different Membrane Packing Densities.
800 mL/min Dialysate Flow Rate
|
340 Whole blood urea clearance (mL/min)
Standard Error 3
|
320 Whole blood urea clearance (mL/min)
Standard Error 3
|
313 Whole blood urea clearance (mL/min)
Standard Error 4
|
327 Whole blood urea clearance (mL/min)
Standard Error 5
|
PRIMARY outcome
Timeframe: During the third treatment with each dialyzer (one time during each trial period week)Outcome measures
| Measure |
HD-C4 Big
n=12 Participants
3 consecutive treatments with the HD-C4 Big dialyzer.
|
HD-C4 Small
n=12 Participants
3 consecutive treatments with the HD-C4 Small dialyzer.
|
F160NR
n=12 Participants
3 consecutive treatments with the F160NR dialyzer.
|
F200NR
n=12 Participants
3 consecutive treatments with the F200NR dialyzer.
|
|---|---|---|---|---|
|
Effect of Increased Dialysate Flow Rate on KoA for Phosphorus Between 4 Dialyzers With Different Membrane Packing Densities.
350 mL/min Dialysate Flow Rate
|
434 KoA for Phosphorus (mL/min)
Standard Error 48
|
334 KoA for Phosphorus (mL/min)
Standard Error 24
|
434 KoA for Phosphorus (mL/min)
Standard Error 34
|
504 KoA for Phosphorus (mL/min)
Standard Error 58
|
|
Effect of Increased Dialysate Flow Rate on KoA for Phosphorus Between 4 Dialyzers With Different Membrane Packing Densities.
500 mL/min Dialysate Flow Rate
|
435 KoA for Phosphorus (mL/min)
Standard Error 31
|
422 KoA for Phosphorus (mL/min)
Standard Error 48
|
450 KoA for Phosphorus (mL/min)
Standard Error 62
|
491 KoA for Phosphorus (mL/min)
Standard Error 29
|
|
Effect of Increased Dialysate Flow Rate on KoA for Phosphorus Between 4 Dialyzers With Different Membrane Packing Densities.
800 mL/min Dialysate Flow Rate
|
520 KoA for Phosphorus (mL/min)
Standard Error 39
|
415 KoA for Phosphorus (mL/min)
Standard Error 35
|
458 KoA for Phosphorus (mL/min)
Standard Error 33
|
560 KoA for Phosphorus (mL/min)
Standard Error 40
|
PRIMARY outcome
Timeframe: During the third treatment with each dialyzer (one time during each trial period week)Outcome measures
| Measure |
HD-C4 Big
n=12 Participants
3 consecutive treatments with the HD-C4 Big dialyzer.
|
HD-C4 Small
n=12 Participants
3 consecutive treatments with the HD-C4 Small dialyzer.
|
F160NR
n=12 Participants
3 consecutive treatments with the F160NR dialyzer.
|
F200NR
n=12 Participants
3 consecutive treatments with the F200NR dialyzer.
|
|---|---|---|---|---|
|
Effect of Increased Dialysate Flow Rate on Whole Blood Phosphorus Clearance Between 4 Dialyzers With Different Membrane Packing Densities.
800 mL/min Dialysate Flow Rate
|
286 whole blood phosphorus clearance mL/min
Standard Error 7
|
273 whole blood phosphorus clearance mL/min
Standard Error 7
|
272 whole blood phosphorus clearance mL/min
Standard Error 7
|
281 whole blood phosphorus clearance mL/min
Standard Error 7
|
|
Effect of Increased Dialysate Flow Rate on Whole Blood Phosphorus Clearance Between 4 Dialyzers With Different Membrane Packing Densities.
350 mL/min Dialysate Flow Rate
|
255 whole blood phosphorus clearance mL/min
Standard Error 7
|
252 whole blood phosphorus clearance mL/min
Standard Error 9
|
247 whole blood phosphorus clearance mL/min
Standard Error 6
|
249 whole blood phosphorus clearance mL/min
Standard Error 5
|
|
Effect of Increased Dialysate Flow Rate on Whole Blood Phosphorus Clearance Between 4 Dialyzers With Different Membrane Packing Densities.
500 mL/min Dialysate Flow Rate
|
269 whole blood phosphorus clearance mL/min
Standard Error 10
|
261 whole blood phosphorus clearance mL/min
Standard Error 9
|
260 whole blood phosphorus clearance mL/min
Standard Error 7
|
265 whole blood phosphorus clearance mL/min
Standard Error 7
|
PRIMARY outcome
Timeframe: During the third treatment with each dialyzer (one time during each trial period week)Outcome measures
| Measure |
HD-C4 Big
n=12 Participants
3 consecutive treatments with the HD-C4 Big dialyzer.
|
HD-C4 Small
n=12 Participants
3 consecutive treatments with the HD-C4 Small dialyzer.
|
F160NR
n=12 Participants
3 consecutive treatments with the F160NR dialyzer.
|
F200NR
n=12 Participants
3 consecutive treatments with the F200NR dialyzer.
|
|---|---|---|---|---|
|
Effect of Increased Dialysate Flow Rate on KoA for b2-microglobulin Between 4 Dialyzers With Different Membrane Packing Densities.
350 mL/min Dialysate Flow Rate
|
65 KoA for b2-microglobulin (mL/min)
Standard Error 4
|
61 KoA for b2-microglobulin (mL/min)
Standard Error 2
|
27 KoA for b2-microglobulin (mL/min)
Standard Error 2
|
27 KoA for b2-microglobulin (mL/min)
Standard Error 2
|
|
Effect of Increased Dialysate Flow Rate on KoA for b2-microglobulin Between 4 Dialyzers With Different Membrane Packing Densities.
500 mL/min Dialysate Flow Rate
|
62 KoA for b2-microglobulin (mL/min)
Standard Error 3
|
57 KoA for b2-microglobulin (mL/min)
Standard Error 2
|
28 KoA for b2-microglobulin (mL/min)
Standard Error 2
|
25 KoA for b2-microglobulin (mL/min)
Standard Error 2
|
|
Effect of Increased Dialysate Flow Rate on KoA for b2-microglobulin Between 4 Dialyzers With Different Membrane Packing Densities.
800 mL/min Dialysate Flow Rate
|
64 KoA for b2-microglobulin (mL/min)
Standard Error 3
|
56 KoA for b2-microglobulin (mL/min)
Standard Error 3
|
31 KoA for b2-microglobulin (mL/min)
Standard Error 5
|
21 KoA for b2-microglobulin (mL/min)
Standard Error 1
|
PRIMARY outcome
Timeframe: During the third treatment with each dialyzer (one time during each trial period week)Outcome measures
| Measure |
HD-C4 Big
n=12 Participants
3 consecutive treatments with the HD-C4 Big dialyzer.
|
HD-C4 Small
n=12 Participants
3 consecutive treatments with the HD-C4 Small dialyzer.
|
F160NR
n=12 Participants
3 consecutive treatments with the F160NR dialyzer.
|
F200NR
n=12 Participants
3 consecutive treatments with the F200NR dialyzer.
|
|---|---|---|---|---|
|
Effect of Increased Dialysate Flow Rate on Whole Blood B2-microglobulin Clearance Between 4 Dialyzers With Different Membrane Packing Densities.
350 mL/min Dialysate Flow Rate
|
106 whole blood clearance B2-microglobulin
Standard Error 9
|
119 whole blood clearance B2-microglobulin
Standard Error 6
|
87 whole blood clearance B2-microglobulin
Standard Error 6
|
72 whole blood clearance B2-microglobulin
Standard Error 9
|
|
Effect of Increased Dialysate Flow Rate on Whole Blood B2-microglobulin Clearance Between 4 Dialyzers With Different Membrane Packing Densities.
500 mL/min Dialysate Flow Rate
|
129 whole blood clearance B2-microglobulin
Standard Error 7
|
118 whole blood clearance B2-microglobulin
Standard Error 8
|
86 whole blood clearance B2-microglobulin
Standard Error 10
|
65 whole blood clearance B2-microglobulin
Standard Error 5
|
|
Effect of Increased Dialysate Flow Rate on Whole Blood B2-microglobulin Clearance Between 4 Dialyzers With Different Membrane Packing Densities.
800 mL/min Dialysate Flow Rate
|
118 whole blood clearance B2-microglobulin
Standard Error 7
|
121 whole blood clearance B2-microglobulin
Standard Error 9
|
78 whole blood clearance B2-microglobulin
Standard Error 8
|
75 whole blood clearance B2-microglobulin
Standard Error 7
|
Adverse Events
HD-C4 Big
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HD-C4 Small
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
F160NR
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
F200NR
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place