NCT05465044: INCHVETS

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

Recruiting now NA Last updated 3 June 2025

What this trial tests

NA trial testing Twice-weekly hemodialysis with incremental crossover to thrice-weekly schedule in Chronic Kidney Disease (CKD) Stage 5 in 252 participants. Currently enrolling.

Timeline

1 April 2023

Primary endpoint
30 September 2027

30 September 2027

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	252
Start date	1 April 2023
Primary completion	30 September 2027
Estimated completion	30 September 2027
Sites	6 locations across United States

Drugs / interventions tested

• Twice-weekly hemodialysis with incremental crossover to thrice-weekly schedule
• Thrice-Weekly Hemodialysis

Conditions studied

• Chronic Kidney Disease (CKD) Stage 5 — all drugs for Chronic Kidney Disease (CKD) Stage 5 →
• Kidney Dysfunction Requiring Dialysis (KDRD) — all drugs for Kidney Dysfunction Requiring Dialysis (KDRD) →
• Dialysis Dependency — all drugs for Dialysis Dependency →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with Chronic Kidney Disease (CKD) Stage 5 or Kidney Dysfunction Requiring Dialysis (KDRD). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Incremental dialysis: two complementary views.
   Casino DFG, Murea M, Floege MJ, Zoccali C. · · 2024 · cited 7× · PMID 38404364 · DOI 10.1093/ckj/sfae020
2. The Hemodialysis Prescription: Past, Present, and Future.
   Murea M, Sirich TL. · · 2023 · cited 2× · PMID 37257086 · DOI 10.34067/kid.0000000000000164