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Clinical Trials in Mexico / NCT05465044
Recruiting Not applicable

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

NCT05465044 · tracked via the Priya Life Science Mexico tracker
Sponsor
VA Office of Research and Development
Phase
Not applicable
Started
2023-04-01
Last updated
2026-08-20

Condition(s) studied

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

Investigational drug(s) / intervention(s)

Twice-weekly hemodialysis with incremental crossover to thrice-weekly scheduleThrice-Weekly Hemodialysis

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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change over time in numeric scale of Health-Related Quality of Life (HRQOL) Physical Component Score (PCS) of SF36 questionnaire. — Change over 12 months based on measuring at baseline and at Month 3, 6, 9 and 12
    The primary endpoint under Aim 1 will be HRQOL Physical Component Score (PCS) measured by the SF36, assessed at baseline and Month 3, 6, 9 and 12. SF36 questionnaires will be administered by trained assessors blinded to the intervention assignment using computer adapted telephone interviewing for SF36. It is a numeric value from 0 (worse) to 100 (best HRQOL physical score).

Trial sites (8)

FacilityCityRegionStatus
VA Long Beach Healthcare System, Long Beach, CA Long Beach California Recruiting
VA Greater Los Angeles Healthcare System, West Los Angeles, CA West Los Angeles California Recruiting
VA Connecticut Healthcare System West Haven Campus, West Haven, CT West Haven Connecticut Recruiting
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Boston Massachusetts Recruiting
John D. Dingell VA Medical Center, Detroit, MI Detroit Michigan Recruiting
New Mexico VA Health Care System, Albuquerque, NM Albuquerque New Mexico Recruiting
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY New York New York Recruiting
Memphis VA Medical Center, Memphis, TN Memphis Tennessee Recruiting

More VA Office of Research and Development trials in Mexico

DBT Skills Groups for Veterans at High Risk for Suicide Attempt Active, not recruiting
Pentoxifylline in Diabetic Kidney Disease Active, not recruiting
Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis Recruiting
Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes Recruiting
Enhancing Veteran-Clinical Collaboration in VA PRRCs Recruiting

Other trials for the same condition

PD Catheter Survival: Modified Percutaneous vs Moncrief-Popovich Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05465044 on ClinicalTrials.gov ↗ ← All trials in Mexico