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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Twice-weekly hemodialysis with incremental crossover to thrice-weekly schedule
  • Thrice-Weekly Hemodialysis

Treatment groups

252 Participants
are divided into 2 treatment groups