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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
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

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Emory University
Coordinator of this site? Confirm its status
AtlantaUnited StatesRecruiting
Johns Hopkins University School of Medicine (JHUSM)
Coordinator of this site? Confirm its status
BaltimoreUnited StatesRecruiting
Massachusetts General Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
University of North Carolina, Chapel Hill
Coordinator of this site? Confirm its status
Chapel HillUnited StatesRecruiting
University of Virginia (UVA)
Coordinator of this site? Confirm its status
CharlottesvilleUnited StatesRecruiting
University of Mississippi Medical Center
Coordinator of this site? Confirm its status
JacksonUnited StatesRecruiting
University of Florida
Coordinator of this site? Confirm its status
JacksonvilleUnited StatesRecruiting
Renal Research Institute (RRI)
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
Northwell Health
Coordinator of this site? Confirm its status
QueensUnited StatesRecruiting
Atrium Health Wake Forest Baptist
Coordinator of this site? Confirm its status
Winston-SalemUnited StatesRecruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.