RecruitingNot ApplicableNCT05828823

Incremental Hemodialysis: The TwoPlus Trial

Comparative Effectiveness of an Individualized Model of Hemodialysis Versus Conventional Hemodialysis


Sponsor

Wake Forest University Health Sciences

Enrollment

350 participants

Start Date

Feb 26, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether people who are new to dialysis and still have some remaining kidney function can safely do twice-weekly dialysis sessions instead of the standard three sessions per week. The hypothesis is that twice-weekly dialysis may be sufficient for some patients while reducing burden and improving quality of life. **You may be eligible if...** - You are 18 years or older - You are new to dialysis (started within the past 12 weeks) - You still produce at least 500 mL of urine per day (indicating residual kidney function) - Your blood salt levels and acid-base balance are within acceptable ranges - Your kidney urea clearance is below a certain threshold, indicating you need dialysis support **You may NOT be eligible if...** - Your blood potassium is dangerously high, or your sodium or bicarbonate (acid-base) levels are critically abnormal - You are likely to need a kidney transplant, switch dialysis methods, or move centers within 6 months - You are pregnant or planning to become pregnant - You require large amounts of fluid removal at each dialysis session Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHemodialysis 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)

OTHERHemodialysis 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

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NCT05828823


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