NCT05828823Recruiting
Incremental Hemodialysis: The TwoPlus Trial
Comparative Effectiveness of an Individualized Model of Hemodialysis Versus Conventional Hemodialysis
Source: ClinicalTrials.gov · Last updated 6 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 350 (estimated)
- First submitted
- 29 Mar 2023
- Start date
- 26 Feb 2024
- Primary completion date
- 31 Jul 2030
- Lead sponsor
- Wake Forest University Health Sciences
- Diseases
- Chronic kidney disease
- NCT number
- NCT05828823
What you commit to
- Study type: Interventional
- Planned participants: 350
- From 26 Feb 2024 to the primary completion date, 31 Jul 2030
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- not have experienced severe life events within prior 3 months of enrollment (through direct inquiry from the person)
Other illness
- have no known psychiatric and neurologic disorders (through direct inquiry from the person)
- not be the caregiver for another patient with chronic illness
Lab values
- Pre-HD serum K ≥5.8 mEq/L, Na ≤125 mEq/L, or bicarbonate level ≤17 mEq/L
Age
- be at least 18 years old
Other
- 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 the main caregiver (at patient's choice)
- be a close relative of the patient (spouse, child, sibling, parent, grandchild)
- not be a member of the medical or healthcare team
Who the study is looking for
- 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
Criteria the registry did not label
- Patient eligibility Criteria:
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Johns Hopkins University School of Medicine (JHUSM) Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| University of North Carolina, Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| University of Virginia (UVA) Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
| University of Mississippi Medical Center Coordinator of this site? Confirm its status | Jackson | United States | Recruiting |
| University of Florida Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Renal Research Institute (RRI) Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Northwell Health Coordinator of this site? Confirm its status | Queens | United States | Recruiting |
| Atrium Health Wake Forest Baptist Coordinator of this site? Confirm its status | Winston-Salem | United States | Recruiting |
Related publications
- Patient monitoring in a pragmatic, multicenter trial of incremental hemodialysis: early experience from the TwoPlus randomized controlled trial.BMC Nephrol · 2025 · PMID 41366335
- Protocol for the process evaluation of a randomised clinical trial of incremental-start versus conventional haemodialysis: the TwoPlus study.BMJ Open · 2025 · PMID 41314824
This page is information, not medical advice. Discuss any trial with your doctor.