RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-04-01
Study Completion:2027-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05465044

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Meeting the incremental dialysis eligibility criteria in Table 4\* under the IncHVets Study Protocol.
  3. * Willingness to undergo the randomly assigned modality of 2x/wk vs 3x/wk HD.
  4. * 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.
  5. * Agreeable to receive monthly or more frequent reviews for and interviews, regardless of being assigned to the incremental or conventional dialysis group.
  6. * 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)
  1. * 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.
  2. * A serum potassium level \>6.0 mEq/L during the 4 weeks prior to the study start.

Contacts and Locations

Study Contact

Kamyar Kalantar-Zadeh, MD PhD
CONTACT
(562) 826-8000
Kamyar.Kalantar-Zadeh@va.gov

Principal Investigator

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

Study Locations (Sites)

VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, 90822
United States
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073-1003
United States
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770
United States
New Mexico VA Health Care System, Albuquerque, NM
Albuquerque, New Mexico, 87108-5153
United States
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
New York, New York, 10010-5011
United States
Memphis VA Medical Center, Memphis, TN
Memphis, Tennessee, 38104-2127
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-01
Study Completion Date2027-09-30

Study Record Updates

Study Start Date2023-04-01
Study Completion Date2027-09-30

Terms related to this study

Keywords Provided by Researchers

  • chronic kidney disease (CKD)
  • Residual kidney function (RKF)
  • Uremia
  • End-stage Renal Disease (ESRD)
  • Hemodialysis
  • Dialysis adequacy

Additional Relevant MeSH Terms

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