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Incremental Hemodialysis: The TwoPlus Trial
Sponsor: Wake Forest University Health Sciences
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.
Official title: Comparative Effectiveness of an Individualized Model of Hemodialysis Versus Conventional Hemodialysis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
350
Start Date
2024-02-26
Completion Date
2028-03
Last Updated
2026-01-29
Healthy Volunteers
No
Conditions
Interventions
Hemodialysis twice weekly
Frequency and duration of hemodialysis is tailored to the patient. Adjuvant pharmacotherapy is prescribed to maintain volume, electrolyte and acid-base homeostasis ( e.g., diuretics, sodium bicarbonate and potassium binding patiromer)
Hemodialysis thrice weekly
Conventional hemodialysis regimen
Locations (10)
University of Florida
Jacksonville, Florida, United States
Emory University
Atlanta, Georgia, United States
Johns Hopkins University School of Medicine (JHUSM)
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Renal Research Institute (RRI)
New York, New York, United States
Northwell Health
Queens, New York, United States
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
University of Virginia (UVA)
Charlottesville, Virginia, United States