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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Twice-weekly hemodialysis with incremental crossover to thrice-weekly schedule — OTHER
  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 — OTHER
  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.

Study Details

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.

Key Dates

Start date

Apr 1, 2023

Status verified

May 2025

Primary completion

Sep 30, 2027

Completion

Sep 30, 2027

Study Design

Enrollment

252 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Twice-Weekly Hemodialysis
  Twice-weekly hemodialysis with incremental crossover to thrice-weekly hemodialysis as indicated
• Placebo Comparator: Thrice-Weekly Hemodialysis
  Outright thrice-weekly hemodialysis without option to switch to less frequent dialysis schedule

Primary Outcome Measure

Change over time in numeric scale of Health-Related Quality of Life (HRQOL) Physical Component Score (PCS) of SF36 questionnaire. [ Time Frame: Change over 12 months based on measuring at baseline and at Month 3, 6, 9 and 12 ]

Central Contacts

• Kamyar Kalantar-Zadeh, MD PhD
  (562) 826-8000
  [email protected]

Locations (6)

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