RecruitingNot ApplicableNCT05465044

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

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


Sponsor

VA Office of Research and Development

Enrollment

252 participants

Start Date

Apr 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether starting dialysis twice per week (incremental dialysis) — instead of the standard three times per week — is safe and effective for Veterans with kidney failure who still have some remaining kidney function. The goal is to preserve quality of life and reduce the burden of frequent dialysis early on. **You may be eligible if...** - You are a Veteran being treated at one of the six participating VA centers - You have been diagnosed with end-stage renal disease (kidney failure) and are about to start or recently started dialysis (within 8 weeks) - You meet the clinical criteria for incremental dialysis (some remaining kidney function) - You are willing to be randomly assigned to a dialysis schedule **You may NOT be eligible if...** - You have already been on dialysis for more than 8 weeks - You do not have enough remaining kidney function to qualify for twice-weekly dialysis - You are not receiving care at a participating VA center Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERTwice-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.

OTHERThrice-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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05465044