NCT05828823 · Wake Forest University Health Sciences
Incremental Hemodialysis: The TwoPlus Trial
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Jacksonville, Florida
- Atlanta, Georgia
- Baltimore, Maryland
- Boston, Massachusetts
- Jackson, Mississippi
- New York, New York
- Queens, New York
- Chapel Hill, North Carolina
- Winston-Salem, North Carolina
- Charlottesville, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 22, 2026 · Source of record for eligibility and locations