NCT05465044 Incremental Hemodialysis for Veterans in the First Year of Dialysis (IncHVets)
| NCT ID | NCT05465044 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Chronic Kidney Disease (CKD) Stage 5 |
| Study Type | INTERVENTIONAL |
| Enrollment | 252 participants |
| Start Date | 2023-04-01 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 252 participants in total. It began in 2023-04-01 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Kamyar Kalantar-Zadeh, MD MPH PhD
PRINCIPAL INVESTIGATOR
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Frequently Asked Questions
Who can join the NCT05465044 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Kidney Disease (CKD) Stage 5. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05465044 currently recruiting?
Yes, NCT05465044 is actively recruiting participants. Contact the research team at Kamyar.Kalantar-Zadeh@va.gov for enrollment information.
Where is the NCT05465044 trial being conducted?
This trial is being conducted at Long Beach, United States, West Los Angeles, United States, West Haven, United States, Boston, United States and 4 additional locations.
Who is sponsoring the NCT05465044 clinical trial?
NCT05465044 is sponsored by VA Office of Research and Development. The principal investigator is Kamyar Kalantar-Zadeh, MD MPH PhD at VA Greater Los Angeles Healthcare System, West Los Angeles, CA. The trial plans to enroll 252 participants.
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