Incremental Hemodialysis: The TwoPlus Trial
Start Date
2/26/2024
Completion Date
1/1/2031
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.
Detailed Description
This study will analyze the effects of differentiated care with individualized hemodialysis on patient health related quality of life, fatigue, employment, and caregiver burden in patients with Kidney dysfunction requiring dialysis (KDRD) and appreciable kidney function. This study will compare the outcomes in survival, hospitalization, preservation of the kidney function and quality of life between hemodialysis tailored to each patient needs (incremental) and conventional hemodialysis.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Hemodialysis twice weekly
Hemodialysis thrice weekly
Conditions
Locations
University of Florida
Jacksonville, Florida 32209
United States
Emory University
Atlanta, Georgia 30322
United States
Johns Hopkins University School of Medicine (JHUSM)
Baltimore, Maryland 21218
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
University of Mississippi Medical Center
Jackson, Mississippi 39216
United States
Renal Research Institute (RRI)
New York, New York 10065
United States
Northwell Health
Queens, New York 11427
United States
University of North Carolina Chapel Hill
Chapel Hill, North Carolina 27599
United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina 27157
United States
University of Virginia (UVA)
Charlottesville, Virginia 22904
United States