Incremental Hemodialysis: The TwoPlus Trial
Recruiting · NCT05828823 · Interventional (participants receive a specific treatment) · Lead sponsor: Wake Forest University Health Sciences
View the official record on ClinicalTrials.gov →Interventions studied
Hemodialysis thrice weeklyHemodialysis twice weekly
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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)
Where it is running
10 locations listed across 8 US states.
- 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