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RECRUITING
NCT05828823
NA

Incremental Hemodialysis: The TwoPlus Trial

Sponsor: Wake Forest University Health Sciences

View on ClinicalTrials.gov

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

Interventions

DEVICE

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)

OTHER

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