HemodialysisNCT03874117

Efficacy of Twice Weekly Hemodialysis in Patients With Residual Kidney Function

A study testing Twice Weekly Hemodialysis then Thrice Weekly Hemodialysis and Thrice Weekly Hemodialysis then Twice Weekly Hemodialysis in people with Hemodialysis and Kidney Failure, Chronic, run by Palo Alto Veterans Institute for Research at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Hemodialysis, Kidney Failure, Chronic
What is being tested?: Twice Weekly Hemodialysis then Thrice Weekly Hemodialysis and Thrice Weekly Hemodialysis then Twice Weekly Hemodialysis
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 3 sitesUnited States
Study dates: 1 Jul 2018to 31 May 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

VA Palo Alto Health Care System
Palo Alto, California, 94304
Santa Clara Valley Medical Center
San Jose, California, 95128
Satellite HealthCare
San Jose, California, 95128

Other trials in United States

About this study

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.

Conditions: Hemodialysis, Kidney Failure, Chronic
Being tested: Twice Weekly Hemodialysis then Thrice Weekly Hemodialysis, Thrice Weekly Hemodialysis then Twice Weekly Hemodialysis
Medical subject headings: Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Twice Weekly Hemodialysis then Thrice Weekly HemodialysisOther
Twice weekly hemodialysis for 4 weeks, then thrice weekly hemodialysis for 4 weeks.
Thrice Weekly Hemodialysis then Twice Weekly HemodialysisOther
Thrice weekly hemodialysis for 4 weeks, then twice weekly hemodialysis for 4 weeks.

Study groups in NCT03874117
Study group	Role	What they receive
Twice Weekly Hemodialysis then Thrice Weekly Hemodialysis	Other	Twice weekly hemodialysis for 4 weeks, then thrice weekly hemodialysis for 4 weeks. Receives: Other: Twice Weekly Hemodialysis then Thrice Weekly Hemodialysis
Thrice Weekly Hemodialysis then Twice Weekly Hemodialysis	Other	Thrice weekly hemodialysis for 4 weeks, then twice weekly hemodialysis for 4 weeks. Receives: Other: Thrice Weekly Hemodialysis then Twice Weekly Hemodialysis

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 4 weeks

Secondary outcomes (4)

Solute Concentration
Plasma concentration of p-cresol sulfate
Measured: 4 weeks
Symptom
Dialysis Symptom Index: measures symptom burden on a scale of 0 to 150, with higher scores being worse.
Measured: 4 weeks
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.
Measured: 4 weeks
Digit Symbol Substitution Test
Cognitive test: Digit Symbol Substitution Test, measured in number correct
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 201831 May 2025

First posted14 Mar 2019
Study start1 Jul 2018
Primary completion1 Sep 2024
Study completion31 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HemodialysisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03874117
Sponsor's protocol ID: SIT0003AGG
Other IDs: R01DK118426
Status last verified: Aug 2025
First submitted: 10 Mar 2019
Last updated: 3 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Safety and Efficacy of Empagliflozin in Hemodialysis
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RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
Not yet recruitingPhase 1/2
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
End Stage Renal Disease, Fatigue
Active, not recruiting
Group Exercise Program Supported By Audiovisual Media During Hemodialysis
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All Hemodialysis trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Twice Weekly Hemodialysis in Patients With Residual Kidney Function
ClinicalTrials.gov ID: NCT03874117
Acronym / sponsor ID: SIT0003AGG
Conditions: Hemodialysis, Kidney Failure, Chronic
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Palo Alto Veterans Institute for ResearchUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 1 Jul 2018 (actual)
Primary completion: 1 Sep 2024 (actual)
Study completion: 31 May 2025 (actual)
First posted: 14 Mar 2019 (actual)
Results: Posted 3 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Twice Weekly Hemodialysis then Thrice Weekly Hemodialysis	Other	Other: Twice Weekly Hemodialysis then Thrice Weekly HemodialysisTwice weekly hemodialysis for 4 weeks, then thrice weekly hemodialysis for 4 weeks.
Thrice Weekly Hemodialysis then Twice Weekly Hemodialysis	Other	Other: Thrice Weekly Hemodialysis then Twice Weekly HemodialysisThrice weekly hemodialysis for 4 weeks, then twice weekly hemodialysis for 4 weeks.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Twice Weekly Hemodialysis then Thrice Weekly HemodialysisTwice weekly hemodialysis for 4 weeks, then thrice weekly hemodialysis for 4 weeks.	Other	Twice Weekly Hemodialysis then Thrice Weekly Hemodialysis
Thrice Weekly Hemodialysis then Twice Weekly HemodialysisThrice weekly hemodialysis for 4 weeks, then twice weekly hemodialysis for 4 weeks.	Other	Thrice Weekly Hemodialysis then Twice Weekly Hemodialysis

Primary outcome

QOL: Kidney Disease Quality of Life (KDQOL36)
Time frame: 4 weeks
Kidney Disease Quality of Life: Health-related quality of life, with higher scores being better. Minimum is 0, maximum is 100.

4 secondary outcomes

Solute Concentration
Time frame: 4 weeks
Symptom
Time frame: 4 weeks
Trail B Making Test
Time frame: 4 weeks
Digit Symbol Substitution Test
Time frame: 4 weeks

Results and safety

Results posted to the registry on 3 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Twice Weekly Hemodialysis Then Thrice Weekly Hemodialysis	15	13
Thrice Weekly Hemodialysis Then Twice Weekly Hemodialysis	16	13

Primary outcome: QOL: Kidney Disease Quality of Life (KDQOL36)

Time frame: 4 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Twice Weekly Hemodialysis n = 26	Thrice Weekly Hemodialysis n = 25
Value	74 (17)	72 (21)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 weeks for each intervention. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Twice Weekly Hemodialysis	0 of 26 (0%)	0 of 26 (0%)	0 of 26
Thrice Weekly Hemodialysis	0 of 25 (0%)	0 of 25 (0%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38922689Lee 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.

Related trials for Hemodialysis

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
Not yet recruitingPhase 1/2
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
End Stage Renal Disease, Fatigue
Active, not recruiting
Group Exercise Program Supported By Audiovisual Media During Hemodialysis
Chronic Kidney Failure, Hemodialysis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tammy Sirich, MD principal investigator

Stanford/VA Palo Alto Health Care System

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

QOL: Kidney Disease Quality of Life (KDQOL36) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03874117, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.