Recruiting

Incremental Hemodialysis

Sponsor:

VA Office of Research and Development

Code:

NCT05465044

Conditions

Chronic Kidney Disease (CKD) Stage 5

Kidney Dysfunction Requiring Dialysis (KDRD)

Dialysis Dependency

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Twice-weekly hemodialysis with incremental crossover to thrice-weekly schedule

Thrice-Weekly Hemodialysis

Study Details

Brief 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

Study ID

NCT05465044

Start date

Apr 1, 2023

Status verified date

Aug, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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
  • Meeting the incremental dialysis eligibility criteria in Table 4\* under the IncHVets Study Protocol
  • Willingness to undergo the randomly assigned modality of 2x/week vs. 3x/week HD
  • 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
  • Agreeable to receive monthly or more frequent reviews for and interviews, regardless of being assigned to the incremental or conventional dialysis group
  • 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 (liters per day) and urea clearance (KRU) >3 ml/min (milliliters per minute) 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)

Exclusion Criteria:

  • 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
  • A serum potassium level >6.0 mEq/L (milliequivalents per liter) during the 4 weeks prior to the study start

Study Design

Enrollment

252 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

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.

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.

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 and Locations

Central contacts

Kamyar Kalantar-Zadeh, MD MPH PhD

(310) 478-3711Kamyar.Kalantar-Zadeh@va.gov

Jeffrey Kraut, MD

(310) 478-3711jeffrey.kraut@va.gov

Locations

VA Long Beach Healthcare System, Long Beach, CA

Recruiting

Long Beach, California, United States, 90822

Contacts

Kamyar Kalantar-Zadeh, MD

310-686-7908kamyar.kalantar-zadeh@va.gov

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

Recruiting

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

Contacts

Kamyar Kalantar-Zadeh, MD MPH PhD

(310) 478-3711Kamyar.Kalantar-Zadeh@va.gov

Principal Investigator:

Kamyar Kalantar-Zadeh, MD MPH PhD

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

Recruiting

West Haven, Connecticut, United States, 06516-2770

Contacts

David Geller, MD

203-932-5711david.geller@va.gov

Susan Crowley, MD

2039325711susan.crowley@va.gov

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Recruiting

Boston, Massachusetts, United States, 02130-4817

Contacts

Ian R Rifkin, MD

617-595-1689Ian.Rifkin@va.gov

Britte Beaudette-Zlatanova, PhD

6175951689Britte.beaudette-zlatanova@va.gov

John D. Dingell VA Medical Center, Detroit, MI

Recruiting

Detroit, Michigan, United States, 48201-1916

Contacts

Mili J Shah, MD

313-576-1000Mili.Shah5@va.gov

New Mexico VA Health Care System, Albuquerque, NM

Recruiting

Albuquerque, New Mexico, United States, 87108-5153

Contacts

Mark L Unruh, MD

505-272-0600MLUnruh@salud.unm.edu

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

Recruiting

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

Contacts

David S Goldfarb, MD

212-686-7500David.Goldfarb@va.gov

Memphis VA Medical Center, Memphis, TN

Recruiting

Memphis, Tennessee, United States, 38104-2127

Contacts

Csaba P Kovesdy, MD

901-523-8990csaba.kovesdy@va.gov

More Information

Sponsor

VA Office of Research and Development

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-08-20.