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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 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.

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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.

Conditions Studied

End-Stage Kidney Disease

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

FieldValue
Enrollment Target 350 participants
Start Date 2024-02-26
Est. Completion 2028-03
Phase NA

Sponsor

Wake Forest University Health Sciences

1,140 total trials

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What the Registry Record Tells You About NCT05828823

The ClinicalTrials.gov registry entry for NCT05828823 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 350 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 448-participant average among 20 other End-Stage Kidney Disease trials with a reported enrollment target (22% lower). The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.

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 reports 10 study locations spanning 8 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.