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CompletedNCT03874117Updated Sep 3, 2025Results posted

Efficacy of Twice Weekly Hemodialysis in Patients With Residual Kidney Function

An interventional study of Twice Weekly Hemodialysis then Thrice Weekly Hemodialysis and Thrice Weekly Hemodialysis then Twice Weekly Hemodialysis in Hemodialysis and Kidney Failure, Chronic, sponsored by Palo Alto Veterans Institute for Research. Completed at 3 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-09-03.

Sponsored by Palo Alto Veterans Institute for Research · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jul 2018, registered Mar 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

The study will determine the efficacy of twice weekly hemodialysis in patients with residual kidney function.

Read the 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.

02

Conditions studied

  • Hemodialysis
  • Kidney Failure, Chronic
03

In context

Kidney Failure, Chronic

2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.

This study's enrollment of 58 is close to the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

Palo Alto Veterans Institute for Research is the lead sponsor of 51 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • inability to achieve adequate hemodialysis.
  • planned revision of hemodialysis vascular access.
  • hospitalized within the past 2 months.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
58 participants (actual)

Study arms

  • Other
    Twice Weekly Hemodialysis then Thrice Weekly Hemodialysis

    Twice weekly hemodialysis for 4 weeks, then thrice weekly hemodialysis for 4 weeks.

    Other: Twice Weekly Hemodialysis then Thrice Weekly Hemodialysis

  • Other
    Thrice Weekly Hemodialysis then Twice Weekly Hemodialysis

    Thrice weekly hemodialysis for 4 weeks, then twice weekly hemodialysis for 4 weeks.

    Other: Thrice Weekly Hemodialysis then Twice Weekly Hemodialysis

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.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Solute Concentration

    Plasma concentration of p-cresol sulfate

    Time frame: 4 weeks

  2. Symptom

    Dialysis Symptom Index: measures symptom burden on a scale of 0 to 150, with higher scores being worse.

    Time frame: 4 weeks

  3. 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

  4. Digit Symbol Substitution Test

    Cognitive test: Digit Symbol Substitution Test, measured in number correct

    Time frame: 4 weeks

07

Results

Posted Sep 3, 2025

Participant flow

First Intervention (4 Weeks)
Participant flow — First Intervention (4 Weeks)
MilestoneTwice Weekly Hemodialysis Then Thrice Weekly HemodialysisThrice Weekly Hemodialysis Then Twice Weekly Hemodialysis
Started1516
Completed1313
Not completed23
Withdrew: Received kidney transplant10
Withdrew: Coronavirus disease 2019 (covid-19) imposed restrictions on research11
Withdrew: Withdrawal by subject01
Withdrew: Hospitalized for infection01
Second Intervention (4 Weeks)
Participant flow — Second Intervention (4 Weeks)
MilestoneTwice Weekly Hemodialysis Then Thrice Weekly HemodialysisThrice Weekly Hemodialysis Then Twice Weekly Hemodialysis
Started1313
Completed1213
Not completed10
Withdrew: Withdrawal by subject10

Outcome measures

PrimaryQOL: 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
Reported as:
Mean · score on a scale
QOL: Kidney Disease Quality of Life (KDQOL36)
score on a scaleTwice Weekly HemodialysisThrice Weekly Hemodialysis
QOL: Kidney Disease Quality of Life (KDQOL36)74 ± 1772 ± 21
SecondarySolute Concentration

Plasma concentration of p-cresol sulfate

Time frame:
4 weeks
Reported as:
Mean · mg/dl
Solute Concentration
mg/dlTwice Weekly HemodialysisThrice Weekly Hemodialysis
Solute Concentration3.6 (2.5 to 4.6)3.6 (2.6 to 4.8)
SecondarySymptom

Dialysis Symptom Index: measures symptom burden on a scale of 0 to 150, with higher scores being worse.

Time frame:
4 weeks
Reported as:
Mean · score on a scale
Symptom
score on a scaleTwice Weekly HemodialysisThrice Weekly Hemodialysis
Symptom26 ± 2632 ± 31
SecondaryTrail 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
Reported as:
Mean · seconds
Trail B Making Test
secondsTwice Weekly HemodialysisThrice Weekly Hemodialysis
Trail B Making Test129 ± 73125 ± 84
SecondaryDigit Symbol Substitution Test

Cognitive test: Digit Symbol Substitution Test, measured in number correct

Time frame:
4 weeks
Reported as:
Mean · number correct
Digit Symbol Substitution Test
number correctTwice Weekly HemodialysisThrice Weekly Hemodialysis
Digit Symbol Substitution Test51 ± 2151 ± 20

Adverse events

Collected over 4 weeks for each intervention. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Twice Weekly Hemodialysis0/26 (0%)0/26 (0%)0/26 (0%)
Thrice Weekly Hemodialysis0/25 (0%)0/25 (0%)0/25 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Twice Weekly Hemodialysis Then Thrice Weekly HemodialysisThrice Weekly Hemodialysis Then Twice Weekly HemodialysisTotal
Mean61 ± 1159 ± 1160 ± 11
Sex: Female, Male
Sex: Female, Male(Participants)Twice Weekly Hemodialysis Then Thrice Weekly HemodialysisThrice Weekly Hemodialysis Then Twice Weekly HemodialysisTotal
Female6410
Male91221
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Twice Weekly Hemodialysis Then Thrice Weekly HemodialysisThrice Weekly Hemodialysis Then Twice Weekly HemodialysisTotal
Hispanic or Latino4812
Not Hispanic or Latino11819
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Twice Weekly Hemodialysis Then Thrice Weekly HemodialysisThrice Weekly Hemodialysis Then Twice Weekly HemodialysisTotal
American Indian or Alaska Native000
Asian6410
Native Hawaiian or Other Pacific Islander112
Black or African American000
White81119
More than one race000
Unknown or Not Reported000
Residual kidney urea clearance (Kru)
Residual kidney urea clearance (Kru)(mL/min)Twice Weekly Hemodialysis Then Thrice Weekly HemodialysisThrice Weekly Hemodialysis Then Twice Weekly HemodialysisTotal
Mean5.5 ± 2.14.2 ± 1.64.7 ± 1.9
08

Study locations

3 sites
  • VA Palo Alto Health Care System
    Palo Alto, California 94304, United States
  • Santa Clara Valley Medical Center
    San Jose, California 95128, United States
  • Satellite HealthCare
    San Jose, California 95128, United States
09

References and documents

Publications

  • Lee S, Pham NM, Montez-Rath ME, Bolanos CG, Bonde SS, Meyer TW, Sirich TL. Twice Weekly versus Thrice Weekly Hemodialysis-A Pilot Cross-Over Equivalence Trial. Clin J Am Soc Nephrol. 2024 Sep 1;19(9):1159-1168. doi: 10.2215/CJN.0000000000000507. Epub 2024 Jun 26. PubMed 38922689 ↗

Study documents

  • Study protocol · Apr 30, 2025
  • Statistical analysis plan · Apr 30, 2025

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03874117
Lead sponsor
Palo Alto Veterans Institute for Research
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Tammy Sirich (Principal Investigator, Palo Alto Veterans Institute for Research) — Principal investigator
First posted
Mar 14, 2019
Start date
Jul 1, 2018
Primary completion
Sep 1, 2024
Completion
May 31, 2025
Results posted
Sep 3, 2025
Last update
Sep 3, 2025

Study contacts

Tammy Sirich, MD
principal investigator · Stanford/VA Palo Alto Health Care System

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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