Hemodialysis, Kidney Failure, Chronic
Conditions
Brief summary
The study will determine the efficacy of twice weekly hemodialysis in patients with residual kidney function.
Detailed description
Hemodialysis patients who have residual kidney function will undergo two 4-week study (twice weekly versus thrice weekly hemodialysis) using a cross-over design. Blood, urine, and dialysate samples will be collected at the end of each study period to determine adequacy of treatment and to assess uremic solute levels. Participants will complete quality of life questionnaires and cognitive paper tests.
Interventions
OTHERTwice Weekly Hemodialysis then Thrice Weekly Hemodialysis
Twice weekly hemodialysis for 4 weeks, then thrice weekly hemodialysis for 4 weeks.
OTHERThrice Weekly Hemodialysis then Twice Weekly Hemodialysis
Thrice weekly hemodialysis for 4 weeks, then twice weekly hemodialysis for 4 weeks.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Palo Alto Veterans Institute for Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* patients on hemodialysis who have residual kidney function with residual urea clearance (Kru) \>2.5 mL/min. * been on hemodialysis for at least 3 months. * adherence to regular dialysis treatments.
Exclusion criteria
* inability to achieve adequate hemodialysis. * planned revision of hemodialysis vascular access. * hospitalized within the past 2 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QOL: Kidney Disease Quality of Life (KDQOL36) | 4 weeks | Kidney Disease Quality of Life: Health-related quality of life, with higher scores being better. Minimum is 0, maximum is 100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Solute Concentration | 4 weeks | Plasma concentration of p-cresol sulfate |
| Symptom | 4 weeks | Dialysis Symptom Index: measures symptom burden on a scale of 0 to 150, with higher scores being worse. |
| Trail B Making Test | 4 weeks | Cognitive 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. |
| Digit Symbol Substitution Test | 4 weeks | Cognitive test: Digit Symbol Substitution Test, measured in number correct |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Twice Weekly Hemodialysis Then Thrice Weekly Hemodialysis Twice weekly hemodialysis for 4 weeks, then thrice weekly hemodialysis for 4 weeks. | 15 |
| Thrice Weekly Hemodialysis Then Twice Weekly Hemodialysis Thrice weekly hemodialysis for 4 weeks, then twice weekly hemodialysis for 4 weeks. | 16 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention (4 Weeks) | Coronavirus Disease 2019 (COVID-19) imposed restrictions on research | 1 | 1 |
| First Intervention (4 Weeks) | hospitalized for infection | 0 | 1 |
| First Intervention (4 Weeks) | received kidney transplant | 1 | 0 |
| First Intervention (4 Weeks) | Withdrawal by Subject | 0 | 1 |
| Second Intervention (4 Weeks) | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Twice Weekly Hemodialysis Then Thrice Weekly Hemodialysis | Total | Thrice Weekly Hemodialysis Then Twice Weekly Hemodialysis |
|---|---|---|---|
| Age, Continuous | 61 years STANDARD_DEVIATION 11 | 60 years STANDARD_DEVIATION 11 | 59 years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 12 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 19 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 10 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 19 Participants | 11 Participants |
| Residual kidney urea clearance (Kru) | 5.5 mL/min STANDARD_DEVIATION 2.1 | 4.7 mL/min STANDARD_DEVIATION 1.9 | 4.2 mL/min STANDARD_DEVIATION 1.6 |
| Sex: Female, Male Female | 6 Participants | 10 Participants | 4 Participants |
| Sex: Female, Male Male | 9 Participants | 21 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 25 |
| other Total, other adverse events | 0 / 26 | 0 / 25 |
| serious Total, serious adverse events | 0 / 26 | 0 / 25 |
Outcome results
Primary
QOL: Kidney Disease Quality of Life (KDQOL36)
Kidney Disease Quality of Life: Health-related quality of life, with higher scores being better. Minimum is 0, maximum is 100.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Twice Weekly Hemodialysis | QOL: Kidney Disease Quality of Life (KDQOL36) | 74 score on a scale | Standard Deviation 17 |
| Thrice Weekly Hemodialysis | QOL: Kidney Disease Quality of Life (KDQOL36) | 72 score on a scale | Standard Deviation 21 |
Secondary
Digit Symbol Substitution Test
Cognitive test: Digit Symbol Substitution Test, measured in number correct
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Twice Weekly Hemodialysis | Digit Symbol Substitution Test | 51 number correct | Standard Deviation 21 |
| Thrice Weekly Hemodialysis | Digit Symbol Substitution Test | 51 number correct | Standard Deviation 20 |
Secondary
Solute Concentration
Plasma concentration of p-cresol sulfate
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Twice Weekly Hemodialysis | Solute Concentration | 3.6 mg/dl |
| Thrice Weekly Hemodialysis | Solute Concentration | 3.6 mg/dl |
Secondary
Symptom
Dialysis Symptom Index: measures symptom burden on a scale of 0 to 150, with higher scores being worse.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Twice Weekly Hemodialysis | Symptom | 26 score on a scale | Standard Deviation 26 |
| Thrice Weekly Hemodialysis | Symptom | 32 score on a scale | Standard Deviation 31 |
Secondary
Trail B Making Test
Cognitive 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.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Twice Weekly Hemodialysis | Trail B Making Test | 129 seconds | Standard Deviation 73 |
| Thrice Weekly Hemodialysis | Trail B Making Test | 125 seconds | Standard Deviation 84 |