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Could fewer dialysis sessions preserve kidney function and boost quality of life?

NCT ID NCT05465044

Disease control Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial explores whether starting dialysis twice a week instead of the standard three times a week, with a gradual increase over a year, can improve quality of life and preserve remaining kidney function in veterans with advanced kidney disease. Participants are randomly assigned to either the incremental schedule or the usual thrice-weekly regimen. The study tracks physical health, energy levels, and safety outcomes to see if a less frequent start is a viable option.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Twice-weekly hemodialysis with gradual increase to thrice-weekly, compared to standard thrice-weekly hemodialysis
What this could lead to
If successful, this could show that starting dialysis less often is safe and may improve quality of life while preserving remaining kidney function, potentially reducing healthcare costs.
What could go wrong
This is a pragmatic trial with a moderate sample size; results may not apply to all patients, and less frequent dialysis could carry risks such as inadequate clearance or fluid overload.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 252 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult Veterans diagnosed with ESRD and who will soon need chronic dialysis initiation or have initiated hemodialysis (HD) not longer than 8 weeks of the target randomization day in one of the six VA centers * Meeting the incremental dialysis eligibility criteria in Table 4\* under the IncHVets Study Protocol * Willingness to undergo the randomly assigned modality of 2x/week vs. 3x/week HD * Willingness to attend the baseline and quarterly study tests in the dialysis unit or via telehealth as determined by study staff, which will mostly be parallel to the routine dialysis clinic visits * Agreeable to receive monthly or more frequent reviews for and interviews, regardless of being assigned to the incremental or conventional dialysis group * As shown in Table 4 of the INCHVETS Study protocol under incremental dialysis criteria, eligible subjects must have a urine output \>0.5 L/day (liters per day) and urea clearance (KRU) \>3 ml/min (milliliters per minute) and meet 5 or more of the 9 other incremental dialysis criteria, which are derived from the 2014 Incremental Dialysis Consensus paper (Kalantar-Zadeh et al. Twice-weekly and incremental hemodialysis treatment for initiation of kidney replacement therapy. Am J Kidney Dis. 2014 Aug;64(2):181-6. doi: 10.1053/j.ajkd.2014.04.019. PMID: 24840669 PMCID: PMC4111970) Exclusion Criteria: * Having a terminal illness with a life expectancy less than 6 months such as stage 4 metastatic cancer or having signed for hospice with life expectancy less than 6 months * A serum potassium level \>6.0 mEq/L (milliequivalents per liter) during the 4 weeks prior to the study start

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome end stage renal failure uremia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic kidney disease (CKD) stage 5 Dialysis dependency Kidney dysfunction requiring dialysis (KDRD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • John D. Dingell VA Medical Center, Detroit, MI

    RECRUITING

    Detroit, Michigan, 48201-1916, United States

  • Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

    RECRUITING

    New York, New York, 10010-5011, United States

  • Memphis VA Medical Center, Memphis, TN

    RECRUITING

    Memphis, Tennessee, 38104-2127, United States

  • New Mexico VA Health Care System, Albuquerque, NM

    RECRUITING

    Albuquerque, New Mexico, 87108-5153, United States

  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    RECRUITING

    Boston, Massachusetts, 02130-4817, United States

  • VA Connecticut Healthcare System West Haven Campus, West Haven, CT

    RECRUITING

    West Haven, Connecticut, 06516-2770, United States

  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA

    RECRUITING

    West Los Angeles, California, 90073-1003, United States

  • VA Long Beach Healthcare System, Long Beach, CA

    RECRUITING

    Long Beach, California, 90822, United States

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