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Incremental Hemodialysis: The TwoPlus Trial
NCT05828823 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05828823
The ClinicalTrials.gov registry entry for NCT05828823 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 350 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,061 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05828823 reports 10 study locations spanning 8 distinct geographic areas — top geographies include New York, North Carolina, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05828823?
The interventions under investigation include: Hemodialysis twice weekly (DEVICE), Hemodialysis thrice weekly (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05828823?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,061 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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