Incremental Hemodialysis: The TwoPlus Trial

Description

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.

Conditions

End-Stage Kidney Disease

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Study Overview

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Study Details

Study overview

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.

Comparative Effectiveness of an Individualized Model of Hemodialysis Versus Conventional Hemodialysis

Incremental Hemodialysis: The TwoPlus Trial

Condition
End-Stage Kidney Disease
Intervention / Treatment

-

Contacts and Locations

Jacksonville

University of Florida, Jacksonville, Florida, United States, 32209

Atlanta

Emory University, Atlanta, Georgia, United States, 30322

Baltimore

Johns Hopkins University School of Medicine (JHUSM), Baltimore, Maryland, United States, 21218

New York

Renal Research Institute (RRI), New York, New York, United States, 10065

Chapel Hill

University of North Carolina Chapel Hill, Chapel Hill, North Carolina, United States, 27599

Winston-Salem

Atrium Health Wake Forest Baptist, Winston-Salem, North Carolina, United States, 27157

Cleveland

Cleveland Clinic, Case Western Reserve University (CWRU), Cleveland, Ohio, United States, 44106

Charlottesville

University of Virginia (UVA), Charlottesville, Virginia, United States, 22904

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Clinical
  • * 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
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Wake Forest University Health Sciences,

Mariana Murea, MD, PRINCIPAL_INVESTIGATOR, Wake Forest Health Sciences

Peter Kotanko, PRINCIPAL_INVESTIGATOR, Renal Research Institute

Study Record Dates

2028-03