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NCT05828823 · ClinicalTrials.gov registry record · NA
Incremental Hemodialysis: The TwoPlus Trial
A NA study of End-Stage Kidney Disease, sponsored by Wake Forest University Health Sciences.
- Recruiting
- Registry status
- NA
- Development phase
- 350
- Enrollment target
- 10
- Study locations
NCT05828823: Recruiting NA study of End-Stage Kidney Disease, sponsored by Wake Forest University Health Sciences.
NCT05828823 is a NA study of End-Stage Kidney Disease that is actively recruiting participants, run by Wake Forest University Health Sciences. The registered enrollment target is 350 participants, below the 448-participant average among 20 other End-Stage Kidney Disease trials with a reported enrollment target (22% lower). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05828823, a NA study of End-Stage Kidney Disease, is actively recruiting participants, sponsored by Wake Forest University Health Sciences.
- RECRUITING
- Registry status
- NA
- Development phase
- 350 participants
- Enrollment target
- 10
- Study locations
Study Summary
This study is to prospectively compare clinical effectiveness between clinically- matched incremental hemodialysis and conventional hemodialysis in patients with incident kidney dysfunction requiring dialysis and residual kidney function. The study will enroll 350 patients on chronic hemodialysis and 140 caregivers of enrolled patients. Patients will be randomized in 1:1 ratio to either incremental start hemodialysis or conventional hemodialysis. Caregivers will be followed along with patients for an average period of 2 years post randomization.
Primary Outcome
composite of all-cause Emergency Department visits, hospitalizations, or death
Conditions Studied
Interventions
- DEVICE Hemodialysis twice weekly
- OTHER Hemodialysis thrice weekly
Study Locations (10)
New York
- Renal Research Institute (RRI) - New York
- Northwell Health - Queens
North Carolina
- University of North Carolina Chapel Hill - Chapel Hill
- Atrium Health Wake Forest Baptist - Winston-Salem
Florida
- University of Florida - Jacksonville
Georgia
- Emory University - Atlanta
Maryland
- Johns Hopkins University School of Medicine (JHUSM) - Baltimore
Massachusetts
- Massachusetts General Hospital - Boston
Mississippi
- University of Mississippi Medical Center - Jackson
Virginia
- University of Virginia (UVA) - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2024-02-26 |
| Est. Completion | 2028-03 |
| Phase | NA |
What NCT05828823 shows while recruiting
NCT05828823 is an interventional study that assigns participants to a tested intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, below the 448-participant average among 20 other End-Stage Kidney Disease trials with a reported enrollment target (22% lower).
The record links to 1 condition, with End-Stage Kidney Disease appearing as the primary indexed condition, and to 2 interventions - of which Hemodialysis twice weekly is the first listed.
NCT05828823 lists 10 locations in 8 states (New York, North Carolina, Florida).
Frequently Asked Questions
What is clinical trial NCT05828823 about?
NCT05828823 is a clinical study titled "Incremental Hemodialysis: The TwoPlus Trial". This study is to prospectively compare clinical effectiveness between clinically- matched incremental hemodialysis and conventional hemodialysis in patients with incident kidney dysfunction requiring dialysis and residual kidney function. The study will enroll 350 patients on chronic hemodialysis a...
What is the current status of trial NCT05828823?
This trial is currently recruiting. It is a NA study. The enrollment target is 350 participants. The study started on 2024-02-26. Estimated completion is 2028-03.
What conditions does trial NCT05828823 study?
This clinical trial studies the following conditions: End-Stage Kidney Disease.
What interventions are being tested in trial NCT05828823?
The interventions under investigation include: Hemodialysis twice weekly (DEVICE), Hemodialysis thrice weekly (OTHER).
Who is sponsoring clinical trial NCT05828823?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05828823 being conducted?
This trial has 10 study locations across Florida, Georgia, Maryland, Massachusetts, Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for End-Stage Kidney Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05828823's enrollment target sits among peer trials
350 5th of 20 higher than 16 of 20 other End-Stage Kidney Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other End-Stage Kidney Disease 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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