Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05465044

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

Led by VA Office of Research and Development · Updated on 2025-06-03

252

Participants Needed

6

Research Sites

234 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult Veterans diagnosed with end-stage kidney disease who need to start or have started hemodialysis within 8 weeks at one of six VA centers
  • Meet incremental dialysis eligibility criteria including urine output greater than 0.5 L/day and urea clearance over 3 ml/min plus at least 5 of 9 other criteria
  • Willing to undergo assigned dialysis schedule of twice or thrice weekly
  • Able to attend baseline and quarterly study tests in dialysis unit or via telehealth
  • Agreeable to monthly or more frequent reviews and interviews during the study
Not Eligible

You will not qualify if you...

  • Terminal illness with life expectancy less than 6 months, such as stage 4 metastatic cancer or hospice care with limited life expectancy
  • Serum potassium level higher than 6.0 mEq/L during the 4 weeks before study start

AI-Screening

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Trial Site Locations

Total: 6 locations

1

VA Long Beach Healthcare System, Long Beach, CA

Long Beach, California, United States, 90822

Actively Recruiting

2

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, United States, 90073-1003

Actively Recruiting

3

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, United States, 06516-2770

Actively Recruiting

4

New Mexico VA Health Care System, Albuquerque, NM

Albuquerque, New Mexico, United States, 87108-5153

Actively Recruiting

5

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

New York, New York, United States, 10010-5011

Actively Recruiting

6

Memphis VA Medical Center, Memphis, TN

Memphis, Tennessee, United States, 38104-2127

Actively Recruiting

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Research Team

K

Kamyar Kalantar-Zadeh, MD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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