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

NCT05465044 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2025-06-03

No results posted yet for this study

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.

Conditions

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

Interventions

OTHER

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.

OTHER

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.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2027-09-30
Completion
2027-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05465044 on ClinicalTrials.gov