Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
252 (estimated)
Sponsor
VA Office of Research and Development · Federal
Who this trial is looking for
This trial is looking for Veterans who have kidney disease and need to start dialysis. Participants may be assigned to receive dialysis less often or the usual frequency, and will be monitored over the year.
Are You a Good Fit for This Trial?
You may be able to join if
I am an adult Veteran with end-stage renal disease (ESRD).
I need to start chronic dialysis soon.
I am willing to follow the assigned dialysis schedule.
I agree to attend tests and check-ins during treatment.
I have a urine output greater than 0.5 liters per day.
I meet 5 or more other specific criteria for dialysis.
You may not be able to join if
I have a terminal illness with a life expectancy of less than 6 months.
I have a potassium level greater than 6.0 mEq/L in the month before the study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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. tw…
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.
Trial Locations
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State
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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\* u…
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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