Actively Recruiting
Incremental Hemodialysis: The TwoPlus Trial
Led by Wake Forest University Health Sciences · Updated on 2026-01-29
350
Participants Needed
10
Research Sites
209 weeks
Total Duration
On this page
Sponsors
W
Wake Forest University Health Sciences
Lead Sponsor
P
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Incremental Hemodialysis: The TwoPlus Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Incident kidney dysfunction requiring dialysis started or expected to start maintenance in-center hemodialysis within 12 weeks
- Received 36 or fewer intermittent hemodialysis sessions (up to 12 weeks) at enrollment
- Kidney urea clearance less than 2.0 mL/min
- Urine volume of 500 mL or more per 24 hours
You will not qualify if you...
- Pre-hemodialysis serum potassium 5.8 mEq/L or higher, sodium less than 125 mEq/L, or bicarbonate less than 17 mEq/L
- Need or expected need for high-volume ultrafiltration
- Unable or unwilling to follow the study protocol
- Known pregnancy, planning pregnancy, or currently lactating
- Estimated survival less than 6 months, expected dialysis modality change, or center transfer within 6 months
- Caregivers must be at least 18 years old, main caregiver chosen by patient, close relative (spouse, child, sibling, parent, grandchild)
- Caregivers must have no known psychiatric or neurologic disorders
- Caregivers must not be medical/healthcare team members
- Caregivers cannot be caregivers for another chronically ill patient
- Caregivers must not have experienced severe life events within 3 months before enrollment
AI-Screening
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Trial Site Locations
Total: 10 locations
1
University of Florida
Jacksonville, Florida, United States, 32209
Actively Recruiting
2
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
Johns Hopkins University School of Medicine (JHUSM)
Baltimore, Maryland, United States, 21218
Actively Recruiting
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
5
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Actively Recruiting
6
Renal Research Institute (RRI)
New York, New York, United States, 10065
Actively Recruiting
7
Northwell Health
Queens, New York, United States, 11427
Actively Recruiting
8
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
9
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
10
University of Virginia (UVA)
Charlottesville, Virginia, United States, 22904
Actively Recruiting
Research Team
B
Brenda Burciu
CONTACT
B
Ben Bagwell
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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