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NCT05828823NARecruiting

Incremental Hemodialysis: The TwoPlus Trial

Wake Forest University Health Sciences

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

Patient eligibility Criteria: Inclusion Criteria: * Clinical Inclusion Criteria: * Age ≥ 18 years * Incident kidney dysfunction requiring dialysis (KDRD) started on maintenance, in-center hemodialysis (HD), or anticipated to be started on maintenance, in-center HD within the next 12 weeks * Has received ≤36 sessions of intermittent HD (i.e., on HD for ≤12 weeks) at the time patient is approached for potential study participation Residual Kidney Function Inclusion Criteria: * Kidney urea clearance \<2.0 mL/min * Urine volume# of ≥500 mL/24 h Exclusion Criteria: * Pre-HD serum K ≥5.8 mEq/L, Na ≤125 mEq/L, or bicarbonate level ≤17 mEq/L * Requirement or anticipated requirement of high-volume ultrafiltration * Unable or unwilling to follow the study protocol for any reason * Known pregnancy or planning to attempt to become pregnant or lactating women * Estimated survival or dialysis modality change or center transfer \<6 months Caregiver Eligibility Criteria: * be at least 18 years old * be the main caregiver (at patient's choice) * be a close relative of the patient (spouse, child, sibling, parent, grandchild) * have no known psychiatric and neurologic disorders (through direct inquiry from the person) * not be a member of the medical or healthcare team * not be the caregiver for another patient with chronic illness * not have experienced severe life events within prior 3 months of enrollment (through direct inquiry from the person)

Interventions

DEVICE

Hemodialysis twice weekly

OTHER

Hemodialysis thrice weekly

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Conditions

End-Stage Kidney Disease

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