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Incremental Hemodialysis for Veterans in the First Year of Dialysis (IncHVets)
Sponsor: VA Office of Research and Development
Summary
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.
Official title: Incremental Hemodialysis for Veterans in the First Year of Dialysis (IncHVets): A Pragmatic, Multi-Center, Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
252
Start Date
2023-04-01
Completion Date
2027-09-30
Last Updated
2025-06-03
Healthy Volunteers
No
Conditions
Interventions
Twice-weekly hemodialysis with incremental crossover to thrice-weekly schedule
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
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.
Locations (6)
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
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