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The TwoPlus Trial: Comparing Hemodialysis Approaches

This study, called The TwoPlus Trial, is looking at two different ways to provide hemodialysis for people with end-stage kidney disease. One approach is "incremental hemodialysis," where you receive dialysis twice a week, and the frequency and duration are adjusted specifically for you. This approach may also include other medications like diuretics, sodium bicarbonate, and patiromer. The other approach is "conventional hemodialysis," which is typically three times a week. The study wants to see if the incremental approach is as effective as the conventional one. You might be able to join if you are 18 or older and have recently started or are about to start hemodialysis. The main goal is to compare the number of safety-related clinical events over two years. This study is currently unclear about its recruitment status.

Study design
This is an interventional study planning to enroll 350 patients. Patients will be randomly assigned to receive either incremental or conventional hemodialysis.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for an average period of 2 years after randomization.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05828823

Incremental Hemodialysis: The TwoPlus Trial

Recruiting
NAAges 18+InterventionalTreatment
Wake Forest University Health Sciences
~350 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:Hemodialysis twice weeklyHemodialysis thrice weekly

At a glance

Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Clinical events of safety
Measured over year 2

Conditions

End-Stage Kidney Disease

Explore related trials

Chronic Renal Failure

Where it's being run

10 sites across 8 states
New York2
North Carolina2
Florida1
Georgia1
Maryland1
Massachusetts1
Mississippi1
Virginia1

Study leadership

  • Mariana Murea, MD · PRINCIPAL_INVESTIGATOR · Wake Forest Health Sciences
  • Peter Kotanko · PRINCIPAL_INVESTIGATOR · Renal Research Institute

Who to contact

Brenda Burciu
[email protected]
336-716-8671
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
Kidney urea clearance ≥ 2.0 mL/min
Urine volume# of ≥500 mL/24 h

Exclusion

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
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)

What this trial measures

  • Number of Clinical events of safetyyear 2

    composite of all-cause Emergency Department visits, hospitalizations, or death