Incremental Hemodialysis: The TwoPlus Trial
Eligible age
18+ yrs
Accepts
All genders
Locations
8 states
Healthy volunteers
No
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About this study
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.
Sponsor: Wake Forest University Health Sciences
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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)
Where it's recruiting
Jacksonville
Atlanta
Baltimore
Boston
Jackson
New York · Queens
Chapel Hill · Winston-Salem
Charlottesville
Source: ClinicalTrials.gov · NCT05828823 · last updated 2026-08-06