RECRUITING

Incremental Hemodialysis: The TwoPlus Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Comparative Effectiveness of an Individualized Model of Hemodialysis Versus Conventional Hemodialysis

Quick Facts

Study Start:2024-02-26
Study Completion:2028-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05828823

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Clinical
  1. * Pre-HD serum K ≥5.8 mEq/L, Na ≤125 mEq/L, or bicarbonate level ≤17 mEq/L
  2. * Requirement or anticipated requirement of high-volume ultrafiltration
  3. * Unable or unwilling to follow the study protocol for any reason
  4. * Known pregnancy or planning to attempt to become pregnant or lactating women
  5. * Estimated survival or dialysis modality change or center transfer \<6 months
  6. * be at least 18 years old
  7. * be the main caregiver (at patient's choice)
  8. * be a close relative of the patient (spouse, child, sibling, parent, grandchild)
  9. * have no known psychiatric and neurologic disorders (through direct inquiry from the person)
  10. * not be a member of the medical or healthcare team
  11. * not be the caregiver for another patient with chronic illness
  12. * not have experienced severe life events within prior 3 months of enrollment (through direct inquiry from the person)

Contacts and Locations

Study Contact

Denisse A Funes
CONTACT
336-716-8671
dfunes@wakehealth.edu
Brindusa Burciu
CONTACT
3367168671
bburciu@wakehealth.edu

Principal Investigator

Mariana Murea, MD
PRINCIPAL_INVESTIGATOR
Wake Forest Health Sciences
Peter Kotanko
PRINCIPAL_INVESTIGATOR
Renal Research Institute

Study Locations (Sites)

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
Renal Research Institute (RRI)
New York, New York, 10065
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
Cleveland Clinic, Case Western Reserve University (CWRU)
Cleveland, Ohio, 44106
United States
University of Virginia (UVA)
Charlottesville, Virginia, 22904
United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

  • Mariana Murea, MD, PRINCIPAL_INVESTIGATOR, Wake Forest Health Sciences
  • Peter Kotanko, PRINCIPAL_INVESTIGATOR, Renal Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-26
Study Completion Date2028-03

Study Record Updates

Study Start Date2024-02-26
Study Completion Date2028-03

Terms related to this study

Keywords Provided by Researchers

  • Hemodialysis
  • Clinically-Matched Incremental Hemodialysis

Additional Relevant MeSH Terms

  • End-Stage Kidney Disease