Trial Outcomes & Findings for Efficacy of Twice Weekly Hemodialysis in Patients With Residual Kidney Function (NCT NCT03874117)
NCT ID: NCT03874117
Last Updated: 2025-09-03
Results Overview
Kidney Disease Quality of Life: Health-related quality of life, with higher scores being better. Minimum is 0, maximum is 100.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
58 participants
Primary outcome timeframe
4 weeks
Results posted on
2025-09-03
Participant Flow
58 participants signed informed consent. 27 did not meet trial eligibility criteria during the run-in period and so were not randomized to the study periods. 31 participants were randomized to the study periods.
Participant milestones
| Measure |
Twice Weekly Hemodialysis Then Thrice Weekly Hemodialysis
Participants will undergo hemodialysis twice per week for 4 weeks and then hemodialysis thrice per week for 4 weeks.
|
Thrice Weekly Hemodialysis Then Twice Weekly Hemodialysis
Participants will undergo hemodialysis thrice per week for 4 weeks and then hemodialysis twice per week for 4 weeks.
|
|---|---|---|
|
First Intervention (4 Weeks)
STARTED
|
15
|
16
|
|
First Intervention (4 Weeks)
COMPLETED
|
13
|
13
|
|
First Intervention (4 Weeks)
NOT COMPLETED
|
2
|
3
|
|
Second Intervention (4 Weeks)
STARTED
|
13
|
13
|
|
Second Intervention (4 Weeks)
COMPLETED
|
12
|
13
|
|
Second Intervention (4 Weeks)
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Twice Weekly Hemodialysis Then Thrice Weekly Hemodialysis
Participants will undergo hemodialysis twice per week for 4 weeks and then hemodialysis thrice per week for 4 weeks.
|
Thrice Weekly Hemodialysis Then Twice Weekly Hemodialysis
Participants will undergo hemodialysis thrice per week for 4 weeks and then hemodialysis twice per week for 4 weeks.
|
|---|---|---|
|
First Intervention (4 Weeks)
received kidney transplant
|
1
|
0
|
|
First Intervention (4 Weeks)
Coronavirus Disease 2019 (COVID-19) imposed restrictions on research
|
1
|
1
|
|
First Intervention (4 Weeks)
Withdrawal by Subject
|
0
|
1
|
|
First Intervention (4 Weeks)
hospitalized for infection
|
0
|
1
|
|
Second Intervention (4 Weeks)
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Efficacy of Twice Weekly Hemodialysis in Patients With Residual Kidney Function
Baseline characteristics by cohort
| Measure |
Twice Weekly Hemodialysis Then Thrice Weekly Hemodialysis
n=15 Participants
Twice weekly hemodialysis for 4 weeks, then thrice weekly hemodialysis for 4 weeks.
|
Thrice Weekly Hemodialysis Then Twice Weekly Hemodialysis
n=16 Participants
Thrice weekly hemodialysis for 4 weeks, then twice weekly hemodialysis for 4 weeks.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 11 • n=5 Participants
|
59 years
STANDARD_DEVIATION 11 • n=7 Participants
|
60 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 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
|
|
Residual kidney urea clearance (Kru)
|
5.5 mL/min
STANDARD_DEVIATION 2.1 • n=5 Participants
|
4.2 mL/min
STANDARD_DEVIATION 1.6 • n=7 Participants
|
4.7 mL/min
STANDARD_DEVIATION 1.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksKidney Disease Quality of Life: Health-related quality of life, with higher scores being better. Minimum is 0, maximum is 100.
Outcome measures
| Measure |
Twice Weekly Hemodialysis
n=26 Participants
Participants who received twice weekly hemodialysis in either the first or last 4 weeks of the study.
|
Thrice Weekly Hemodialysis
n=25 Participants
Participants who received thrice weekly hemodialysis in either the first or last 4 weeks of the study.
|
|---|---|---|
|
QOL: Kidney Disease Quality of Life (KDQOL36)
|
74 score on a scale
Standard Deviation 17
|
72 score on a scale
Standard Deviation 21
|
SECONDARY outcome
Timeframe: 4 weeksPlasma concentration of p-cresol sulfate
Outcome measures
| Measure |
Twice Weekly Hemodialysis
n=26 Participants
Participants who received twice weekly hemodialysis in either the first or last 4 weeks of the study.
|
Thrice Weekly Hemodialysis
n=25 Participants
Participants who received thrice weekly hemodialysis in either the first or last 4 weeks of the study.
|
|---|---|---|
|
Solute Concentration
|
3.6 mg/dl
Interval 2.5 to 4.6
|
3.6 mg/dl
Interval 2.6 to 4.8
|
SECONDARY outcome
Timeframe: 4 weeksDialysis Symptom Index: measures symptom burden on a scale of 0 to 150, with higher scores being worse.
Outcome measures
| Measure |
Twice Weekly Hemodialysis
n=26 Participants
Participants who received twice weekly hemodialysis in either the first or last 4 weeks of the study.
|
Thrice Weekly Hemodialysis
n=25 Participants
Participants who received thrice weekly hemodialysis in either the first or last 4 weeks of the study.
|
|---|---|---|
|
Symptom
|
26 score on a scale
Standard Deviation 26
|
32 score on a scale
Standard Deviation 31
|
SECONDARY outcome
Timeframe: 4 weeksCognitive test: The Trail B Making Test assesses working memory, cognitive flexibility, processing speed, and visual-motor tracking. There are numbers and letters on a page. The participant must connect the number to letter in order. For example, they would start at 1 and draw a line to A, then draw a line to 2, then draw a line to B, then draw a line to 3. The time is recorded in seconds.
Outcome measures
| Measure |
Twice Weekly Hemodialysis
n=26 Participants
Participants who received twice weekly hemodialysis in either the first or last 4 weeks of the study.
|
Thrice Weekly Hemodialysis
n=25 Participants
Participants who received thrice weekly hemodialysis in either the first or last 4 weeks of the study.
|
|---|---|---|
|
Trail B Making Test
|
129 seconds
Standard Deviation 73
|
125 seconds
Standard Deviation 84
|
SECONDARY outcome
Timeframe: 4 weeksCognitive test: Digit Symbol Substitution Test, measured in number correct
Outcome measures
| Measure |
Twice Weekly Hemodialysis
n=26 Participants
Participants who received twice weekly hemodialysis in either the first or last 4 weeks of the study.
|
Thrice Weekly Hemodialysis
n=25 Participants
Participants who received thrice weekly hemodialysis in either the first or last 4 weeks of the study.
|
|---|---|---|
|
Digit Symbol Substitution Test
|
51 number correct
Standard Deviation 21
|
51 number correct
Standard Deviation 20
|
Adverse Events
Twice Weekly Hemodialysis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Thrice Weekly Hemodialysis
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