Incremental Hemodialysis for End-Stage Kidney Disease
Incremental Hemodialysis: The TwoPlus Trial
Recruiting
N/AInterventional Study
End-Stage Kidney Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
350 (estimated)
Sponsor
Wake Forest University Health Sciences · Other
Who this trial is looking for
This trial is looking for adults with kidney problems who need dialysis. Participants will either start a new type of dialysis called incremental hemodialysis or a traditional one. The trial will follow them for about two years to compare the outcomes.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have kidney problems that require dialysis.
I have been on dialysis for 12 weeks or less.
I have a kidney urea clearance of at least 2.0 mL/min.
I produce at least 500 mL of urine in 24 hours.
You may not be able to join if
I have high potassium or low sodium levels before dialysis.
I need a large amount of fluid removal during dialysis.
I cannot follow the study rules for any reason.
I am pregnant or planning to become pregnant.
I expect to change my dialysis method or center within the next 6 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 increment…
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.
Trial Locations
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Eligibility Criteria
Patient eligibility Criteria:
Inclusion Criteria:
* 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 re…
Patient eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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)
* 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)
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