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Incremental Hemodialysis for Veterans in the First Year of Dialysis (IncHVets)

This study is looking at two different ways to start hemodialysis (a treatment for kidney failure) for Veterans. You might receive either thrice-weekly hemodialysis, which is the usual care, or twice-weekly hemodialysis that gradually increases to thrice-weekly over a year. The study aims to see if starting with twice-weekly dialysis improves your health-related quality of life (how you feel about your health and daily life) and helps preserve your remaining kidney function. You could be eligible if you are an adult Veteran with end-stage kidney disease who needs to start dialysis or has recently started it, and meet specific criteria for incremental dialysis. The study will measure changes in your quality of life over 12 months.

Study design
This is an interventional study involving 252 Veterans. Participants will be randomly assigned to one of two groups: thrice-weekly hemodialysis or twice-weekly hemodialysis with a gradual increase to thrice-weekly.
What's involved
Participants will receive hemodialysis for up to 12 months, with quality of life measured at baseline and at months 3, 6, 9, and 12.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after starting the study interventions.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05465044

Incremental Hemodialysis for Veterans in the First Year of Dialysis (IncHVets)

Recruiting
NAAges 18+InterventionalTreatment
VA Office of Research and Development
~252 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:Twice-weekly hemodialysis with incremental crossover to thrice-weekly scheduleThrice-Weekly Hemodialysis

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change over time in numeric scale of Health-Related Quality of Life (HRQOL) Physical Component Score (PCS) of SF36 questionnaire.
Measured over Change over 12 months based on measuring at baseline and at Month 3, 6, 9 and 12

Conditions

Chronic Kidney Disease (CKD) Stage 5
Kidney Dysfunction Requiring Dialysis (KDRD)
Dialysis Dependency

Explore related trials

Chronic Renal Failure

Where it's being run

8 sites across 7 states
California2
Connecticut1
Massachusetts1
Michigan1
New Mexico1
New York1
Tennessee1

Study leadership

  • Kamyar Kalantar-Zadeh, MD MPH PhD · PRINCIPAL_INVESTIGATOR · VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Who to contact

Kamyar Kalantar-Zadeh, MD MPH PhD
[email protected]
(310) 478-3711
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change over time in numeric scale of Health-Related Quality of Life (HRQOL) Physical Component Score (PCS) of SF36 questionnaire.Change over 12 months based on measuring at baseline and at Month 3, 6, 9 and 12

    The primary endpoint under Aim 1 will be HRQOL Physical Component Score (PCS) measured by the SF36, assessed at baseline and Month 3, 6, 9 and 12. SF36 questionnaires will be administered by trained assessors blinded to the intervention assignment using computer adapted telephone interviewing for SF36. It is a numeric value from 0 (worse) to 100 (best HRQOL physical score).