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

Sponsor: VA Office of Research and Development • ClinicalTrials.gov ID: NCT05465044

Registry updated: 2026-08-20

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Description

In this pragmatic clinical trial, which will dovetail with Veterans' routine outpatient dialysis clinic visits in six VA medical centers, the investigators will study 252 Veterans with kidney disease who need to start dialysis treatment. If a Veteran is eligible for the study by making enough residual urine, he/she will have a 50% chance to be offered the usual three-times-per-week dialysis vs. twice-per-week dialysis that is gradually increased to three-times per- week over one year. The investigators will compare health-related quality of life, how long residual kidney function lasts, and other measures including safety in these two groups. By conducting this study, the investigators hope to understand 1) whether starting dialysis with less frequency is safe, effective, and can help Veterans and their care-partners to better cope with dialysis, and 2) if incremental dialysis can result in major cost benefits to the VA health care system, thus allowing more patients to stay in VA dialysis clinics vs. being transferred to outside clinics.

Interventions

Twice-weekly hemodialysis with incremental crossover to thrice-weekly schedule (Other)
50% of the eligible participants will be assigned to twice-weekly hemodialysis for up to 12 months with incremental crossover to thrice-weekly hemodialysis as indicated.
Thrice-Weekly Hemodialysis (Other)
50% of the eligible participants will be assigned to outright thrice-weekly hemodialysis, which will be continuation of the initial thrice-weekly schedule during the run-in period, without the option to switch to less frequent dialysis schedule representing the standard of care.

Eligibility criteria

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

Conditions

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

Locations

VA Long Beach Healthcare System, Long Beach, CA — Long Beach, California, United States
VA Greater Los Angeles Healthcare System, West Los Angeles, CA — West Los Angeles, California, United States
VA Connecticut Healthcare System West Haven Campus, West Haven, CT — West Haven, Connecticut, United States
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston, Massachusetts, United States
John D. Dingell VA Medical Center, Detroit, MI — Detroit, Michigan, United States
New Mexico VA Health Care System, Albuquerque, NM — Albuquerque, New Mexico, United States
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY — New York, New York, United States
Memphis VA Medical Center, Memphis, TN — Memphis, Tennessee, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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