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

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.

Conditions

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

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

Study Overview

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Study Details

Study overview

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.

Incremental Hemodialysis for Veterans in the First Year of Dialysis (IncHVets): A Pragmatic, Multi-Center, Randomized Controlled Trial

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

Condition
Chronic Kidney Disease (CKD) Stage 5
Intervention / Treatment

-

Contacts and Locations

Long Beach

VA Long Beach Healthcare System, Long Beach, CA, Long Beach, California, United States, 90822

West Los Angeles

VA Greater Los Angeles Healthcare System, West Los Angeles, CA, West Los Angeles, California, United States, 90073-1003

West Haven

VA Connecticut Healthcare System West Haven Campus, West Haven, CT, West Haven, Connecticut, United States, 06516-2770

Albuquerque

New Mexico VA Health Care System, Albuquerque, NM, Albuquerque, New Mexico, United States, 87108-5153

New York

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY, New York, New York, United States, 10010-5011

Memphis

Memphis VA Medical Center, Memphis, TN, Memphis, Tennessee, United States, 38104-2127

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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/wk vs 3x/wk 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 and urea clearance (KRU) \>3 ml/min 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)
  • * 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 during the 4 weeks prior to the study start.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

VA Office of Research and Development,

Kamyar Kalantar-Zadeh, MD PhD, PRINCIPAL_INVESTIGATOR, VA Long Beach Healthcare System, Long Beach, CA

Study Record Dates

2027-09-30