NCT05465044Recruiting
Incremental Hemodialysis for Veterans in the First Year of Dialysis (IncHVets)
Incremental Hemodialysis for Veterans in the First Year of Dialysis (IncHVets): A Pragmatic, Multi-Center, Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 252 (estimated)
- First submitted
- 8 Jul 2022
- Start date
- 1 Apr 2023
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- VA Office of Research and Development
- Diseases
- Chronic kidney disease
- NCT number
- NCT05465044
What you commit to
- Study type: Interventional
- Planned participants: 252
- From 1 Apr 2023 to the primary completion date, 30 Sept 2027
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Lab values
- A serum potassium level \>6.0 mEq/L (milliequivalents per liter) during the 4 weeks prior to the study start
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| New Mexico VA Health Care System, Albuquerque, NM Coordinator of this site? Confirm its status | Albuquerque | United States | Recruiting |
| VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| John D. Dingell VA Medical Center, Detroit, MI Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| VA Long Beach Healthcare System, Long Beach, CA Coordinator of this site? Confirm its status | Long Beach | United States | Recruiting |
| Memphis VA Medical Center, Memphis, TN Coordinator of this site? Confirm its status | Memphis | United States | Recruiting |
| Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| VA Connecticut Healthcare System West Haven Campus, West Haven, CT Coordinator of this site? Confirm its status | West Haven | United States | Recruiting |
| VA Greater Los Angeles Healthcare System, West Los Angeles, CA Coordinator of this site? Confirm its status | West Los Angeles | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.