Incremental hemodialysis for veterans starting dialysis
Incremental Hemodialysis for Veterans in the First Year of Dialysis (IncHVets): A Pragmatic, Multi-Center, Randomized Controlled Trial
NA · VA Office of Research and Development · NCT05465044
This study tests whether starting hemodialysis less often can help veterans with kidney disease feel better and keep some kidney function longer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 252 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development (fed) |
| Locations | 6 sites (Long Beach, California and 5 other locations) |
| Trial ID | NCT05465044 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of starting hemodialysis with a less frequent schedule for veterans with end-stage renal disease. Participants will be randomly assigned to either a twice-weekly or a standard thrice-weekly dialysis regimen, with the potential to transition to more frequent treatments over the course of a year. The study aims to assess health-related quality of life, preservation of residual kidney function, and safety outcomes between the two groups. Conducted at six VA medical centers, the trial seeks to provide a more personalized approach to dialysis that may improve patient experiences and outcomes.
Who should consider this trial
Good fit: Ideal candidates are adult veterans diagnosed with end-stage renal disease who are about to start or have recently initiated hemodialysis.
Not a fit: Patients who do not have sufficient residual kidney function or who are unable to comply with the study's treatment and follow-up requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the quality of life for veterans undergoing dialysis by reducing treatment burden and improving health outcomes.
How similar studies have performed: While the standard of care is thrice-weekly dialysis, evidence suggests that similar incremental approaches may offer substantial benefits, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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/wk vs 3x/wk 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 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) 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 during the 4 weeks prior to the study start.
Where this trial is running
Long Beach, California and 5 other locations
- VA Long Beach Healthcare System, Long Beach, CA — Long Beach, California, United States (RECRUITING)
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA — West Los Angeles, California, United States (RECRUITING)
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT — West Haven, Connecticut, United States (RECRUITING)
- New Mexico VA Health Care System, Albuquerque, NM — Albuquerque, New Mexico, United States (RECRUITING)
- Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY — New York, New York, United States (RECRUITING)
- Memphis VA Medical Center, Memphis, TN — Memphis, Tennessee, United States (RECRUITING)
Study contacts
- Principal investigator: Kamyar Kalantar-Zadeh, MD PhD — VA Long Beach Healthcare System, Long Beach, CA
- Study coordinator: Kamyar Kalantar-Zadeh, MD PhD
- Email: Kamyar.Kalantar-Zadeh@va.gov
- Phone: (562) 826-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Kidney Disease Stage 5, Kidney Dysfunction Requiring Dialysis, Dialysis Dependency, chronic kidney disease, Residual kidney function, Uremia, End-stage Renal Disease, Hemodialysis