Efficacy of Twice Weekly Hemodialysis in Patients With Residual Kidney Function
Phase: NA
Conditions: Hemodialysis, Kidney Failure, Chronic
Sponsor: Palo Alto Veterans Institute for Research

 
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Efficacy of Twice Weekly Hemodialysis in Patients 
With Residual Kidney Function 
NCT03874117 
April 30, 2025 
 
1. 
PURPOSE OF THE STUDY 
 
a. 
Brief Summary 
This study will test whether hemodialysis two times per week is equally effective as 
hemodialysis three times per week for people who still have some kidney function left. It 
will hopefully show that twice weekly hemodialysis provides the same quality of life as 
three times weekly hemodialysis. Such a finding could reduce the burden of hemodialysis 
and improve people's quality of life. 
 
 
b. 
Objectives 
More than 100,000 people start hemodialysis every year with the majority getting 
treatments three days per week. Many of these people, however, have enough remaining 
kidney function so that they may be able to receive hemodialysis treatments two days 
per week instead of three. We hope to learn whether a proposed formula for twice 
weekly dialysis prescription provides effective treatment for patients with residual native 
kidney function. This knowledge could hopefully reduce the burden on future patients 
and the cost of their treatment. 
 
c. 
Rationale for Research in Humans 
This study will assess the effect of twice weekly dialysis on the quality of life and on 
levels of uremic solutes in patients with residual native kidney function. Therefore, we 
need to include human subjects. 
 
2. 
STUDY PROCEDURES 
 
a. 
Procedures 
Hemodialysis patients with sufficient residual native kidney function will undergo two 
4-week study periods in a cross-over design. During these periods, hemodialysis will be 
prescribed three times per week and two times per week according to a formula put 
forward by a National Kidney Foundation Committee.  
Screening:  
- local nephrologists will be contacted to identify patients with measured residual kidney 
function or patients who report still producing urine.  
- informed consent will be obtained from eligible patients.  
- patients who consent will then undergo a run-in period followed by randomization into 
the cross-over study if they have adequate residual function.  
 

 
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Run-in period: 
- patients' residual kidney function (Kru) will be measured by urine and blood collection.  
- if Kru is >2.5 ml/min, patients will then proceed into the crossover study periods after 
completing the following steps:  
• receive extra dietary counseling in addition to routine dietary advice provided by the 
dialysis unit  
• diuretic doses will be optimized 
 
Cross-over study with two 4-week study periods.  
During each period:  
- hemodialysis will be prescribed to achieve adequate treatment according to current 
National Kidney Foundation Committee guidelines.  
- patients will be visited weekly.  
- patients will continue to obtain blood work monitoring as per their routine dialysis 
care.  
- hemodialysis and medications will be adjusted by the patients' primary nephrologist as 
needed.  
- receive extra dietary counseling in addition to routine dietary advice provided by the 
dialysis unit 
 
At the end of each 4-week period:  
- patients' residual kidney function will be measured.  
- pre- and post-treatment blood samples will be collected at the last treatment of the 
period. Blood will be collected through the dialysis tubing in the same fashion as the 
patients' routine lab monitoring. 
- waste dialysate, which normally gets thrown away, will be collected during the last 
treatment.  
- patients will complete symptom questionnaires and cognitive function tests. 
 
 
b. 
Procedure Risks 
Blood would be collected in the same sterile fashion as the patients' routine lab checks. 
Since the patients are on hemodialysis, blood will be collected in the same fashion as 
their routine monthly labs through the hemodialysis tubing. We will monitor levels of 
common blood chemistry such as serum potassium and CO2 as well as monitor blood 
pressure and weights during the study. We will adjust the hemodialysis prescription and 
medications based on this monitoring. We will visit the patients weekly to monitor for 
any symptoms. Hemodialysis will be prescribed according to current National Kidney 
Foundation Committee guidelines to ensure adequate treatment for the patients. 
 
c. 
Will it be possible to continue the more (most) appropriate therapy for the 
participant(s) after the conclusion of the study? 
Yes 
 
d. 
Study Endpoint(s) 
The primary endpoint is quality of life as assessed by the KDQOL-36, a questionnaire 
designed to assess the symptoms commonly experienced with kidney disease. Other 
endpoints are an additional symptom questionnaire (Dialysis Symptom Index), cognitive 
testing (Trails Making B and Digit Symbol Substitution Test), and plasma levels of 

 
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uremic solutes.  We are testing for equivalency between two approved ways of 
prescribing the hemodialysis.  A Data Safety Monitor will review results regularly and 
report to us and the IRB on any departure from this expectation. If no unexpected 
differences are detected, the study will end once the projected total subject population 
has completed the study. 
 
3. 
BACKGROUND 
 
a. 
Past Experimental and/or Clinical Findings 
We have previously found that the residual native kidney can control 
plasma levels of secreted solutes better than those of the index solute 
urea. We subsequently found that plasma levels of secreted solutes 
were lower or the same in patients on twice weekly hemodialysis 
compared to anuric patients on thrice weekly hemodialysis. 
 
b. 
Findings from Past Animal Experiments 
N/A 
 
 
4. 
DRUGS, BIOLOGICS, REAGENTS, OR CHEMICALS USED IN THE STUDY 
 
a. 
Commercial Drugs, Biologics, Reagents, or Chemicals 
None 
 
5. 
PARTICIPANT POPULATION 
 
a. 
Planned Enrollment 
Approximately 50 subjects expected to be enrolled from Stanford-affiliated sites  
including VA Palo Alto, Satellite Healthcare, and Santa Clara Valley Medical Center.  
 
b. 
Age, Gender, and Ethnic Background 
The age range will be 18 to 85 years old. The gender and ethnic background will be 
representative of the Bay Area population. 
 
c. 
Recruitment Details 
We will notify the primary nephrologists who will help identify patients who are on 
hemodialysis and have residual kidney function. Residual kidney function (Kru) is not 
routinely measured. For those patients who do have Kru measured, they will be eligible for 
the study if Kru is >2.5 ml/min. If no Kru has been measured, a report of urine production 
greater than 500 ml/day (about 1 cup/day) is sufficient. All patients who consent to be in 
the study will then provide 24-hour urine and blood collection during the run-in period as 
described in the study procedures to obtain a Kru measurement before they proceed into 
the study periods. If the measured Kru is >2.5 ml/min, they can proceed into the study 
periods.   If the measured Kru is <2.5 ml/min, they will not proceed further with the study. 
 
d. 
Eligibility Criteria 
i. 
Inclusion Criteria 
- patients on hemodialysis who have residual kidney function with residual urea 
clearance (Kru) >2.5 ml/min.  

 
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- been on hemodialysis for at least 3 months.  
- adherence to regular dialysis treatments. 
ii. 
Exclusion Criteria 
- inability to achieve adequate hemodialysis.  
- planned revision of hemodialysis vascular access.  
- hospitalized within the past 2 months. 
 
e. 
Screening Procedures 
We will notify the primary nephrologists who will help identify patients who are on 
hemodialysis and have residual kidney function. Residual kidney function (Kru) is not 
routinely measured. For those patients who do have Kru measured, they will be eligible for 
the study if Kru is >2.5 ml/min. If no Kru has been measured, a report of urine production 
greater than 500 ml/day (about 1 cup/day) is sufficient.