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NCT05465044 · ClinicalTrials.gov registry record · NA
Incremental Hemodialysis for Veterans in the First Year of Dialysis (IncHVets)
A NA study of Chronic Kidney Disease (CKD) Stage 5 and Kidney Dysfunction Requiring Dialysis (KDRD), sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- NA
- Development phase
- 252
- Enrollment target
- 6
- Study locations
NCT05465044: Recruiting NA study of Chronic Kidney Disease (CKD) Stage 5 and Kidney Dysfunction Requiring Dialysis (KDRD), sponsored by VA Office of Research and Development.
NCT05465044 is a NA study of Chronic Kidney Disease (CKD) Stage 5 and Kidney Dysfunction Requiring Dialysis (KDRD) that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 252 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05465044, a NA study of Chronic Kidney Disease (CKD) Stage 5 and Kidney Dysfunction Requiring Dialysis (KDRD), is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- NA
- Development phase
- 252 participants
- Enrollment target
- 6
- Study locations
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.
Primary Outcome
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).
Conditions Studied
Interventions
- OTHER Twice-weekly hemodialysis with incremental crossover to thrice-weekly schedule
- OTHER Thrice-Weekly Hemodialysis
Study Locations (6)
California
- VA Long Beach Healthcare System, Long Beach, CA - Long Beach
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA - West Los Angeles
Connecticut
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT - West Haven
New Mexico
- New Mexico VA Health Care System, Albuquerque, NM - Albuquerque
New York
- Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY - New York
Tennessee
- Memphis VA Medical Center, Memphis, TN - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 252 participants |
| Start Date | 2023-04-01 |
| Est. Completion | 2027-09-30 |
| Phase | NA |
What NCT05465044 shows while recruiting
NCT05465044 is an interventional study that assigns participants to a tested intervention. The registered 252 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower).
The record links to 3 conditions, with Chronic Kidney Disease (CKD) Stage 5 appearing as the primary indexed condition, and to 2 interventions - of which Twice-weekly hemodialysis with incremental crossover to thrice-weekly schedule is the first listed.
NCT05465044 lists 6 locations in 5 states (California, Connecticut, New Mexico).
Frequently Asked Questions
What is clinical trial NCT05465044 about?
NCT05465044 is a clinical study titled "Incremental Hemodialysis for Veterans in the First Year of Dialysis (IncHVets)". 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 residu...
What is the current status of trial NCT05465044?
This trial is currently recruiting. It is a NA study. The enrollment target is 252 participants. The study started on 2023-04-01. Estimated completion is 2027-09-30.
What conditions does trial NCT05465044 study?
This clinical trial studies the following conditions: Chronic Kidney Disease (CKD) Stage 5, Kidney Dysfunction Requiring Dialysis (KDRD), Dialysis Dependency.
What interventions are being tested in trial NCT05465044?
The interventions under investigation include: Twice-weekly hemodialysis with incremental crossover to thrice-weekly schedule (OTHER), Thrice-Weekly Hemodialysis (OTHER).
Who is sponsoring clinical trial NCT05465044?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05465044 being conducted?
This trial has 6 study locations across California, Connecticut, New Mexico, New York, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05465044's enrollment target sits among peer trials
252 407th of 2000 higher than 1,592 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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