Patient monitoring in a pragmatic, multicenter trial of incremental hemodialysis: early experience from the TwoPlus randomized controlled trial.
Samir C Gautam, Alaa S Awad, Vandana Dua Niyyar...
https://pubmed.ncbi.nlm.nih.gov/41366335/Actively Recruiting
Led by Wake Forest University Health Sciences · Updated on 2026-08-06
350
Participants Needed
10
Research Sites
26 weeks
Total Duration
Researchers are evaluating the clinical effectiveness of incremental hemodialysis compared to conventional hemodialysis in adults with kidney dysfunction who require dialysis but still have some kidney function. The study aims to assess differences in survival, hospitalization, kidney function preservation, quality of life, fatigue, employment, and caregiver burden. This trial is designed to provide personalized dialysis care tailored to patient needs versus the standard thrice-weekly treatment. Participants will be randomized to receive either incremental hemodialysis, starting at twice weekly with individualized adjustments based on residual kidney function, or conventional hemodialysis administered three times a week. The incremental group will also receive additional medications to support body fluid and electrolyte balance. Caregivers of enrolled patients will be followed alongside patients for up to two years after randomization. During the study, patients and their caregivers will be monitored regularly with various assessments including quality of life questionnaires, cognitive tests, caregiver burden scores, urine output and kidney clearance measurements, and hospitalization tracking. Data will be collected at baseline and multiple intervals over two years. Researchers will track clinical safety events and examine how treatments affect daily functioning and recovery time after dialysis sessions.
CONDITIONS
Incremental Hemodialysis: The TwoPlus Trial
B
Brenda Burciu
B
Ben Bagwell
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Wake Forest University Health Sciences
Lead Sponsor
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Incremental Hemodialysis | Conventional Thrice‑Weekly Hemodialysis |
|---|---|---|
| What it is | A randomized investigational regimen using twice‑weekly hemodialysis adjusted for residual kidney function plus supportive medications like diuretics, potassium binder, or sodium bicarbonate | The standard hemodialysis schedule delivered three times per week |
| Primary purpose in trial | Evaluated as an alternative initial dialysis regimen aiming to preserve kidney function and reduce treatment burden | Used as the comparator standard‑care dialysis schedule |
| Evidence status | Evidence for preservation of residual kidney function and similar mortality and hospitalization outcomes exists from systematic reviews of incremental versus conventional hemodialysis | Thrice‑weekly hemodialysis remains the prevailing standard protocol at dialysis initiation in clinical practice |
| Important limitations | May require frequent monitoring of residual kidney function and lab tests; risks include possible underdialysis if clearance declines | May accelerate loss of residual kidney function and increase patient treatment burden |
| Patient‑relevant outcomes | Associated with better preservation of residual kidney function and fewer vascular access complications | Well‑established treatment but linked to quicker loss of kidney function |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive either incremental hemodialysis tailored to their kidney function starting twice weekly or conventional hemodialysis three times a week.
Regular visits for assessments and dialysis sessions
Duration - Up to 2 years
Participants and their caregivers are monitored with periodic assessments of health, kidney function, quality of life, and caregiver burden over the two-year period.
Multiple visits at baseline and months 3, 6, 9, 12, 15, 18, 21, and 24
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Samir C Gautam, Alaa S Awad, Vandana Dua Niyyar...
https://pubmed.ncbi.nlm.nih.gov/41366335/Mariana Murea, Kristie L Foley, Samir C Gautam...
https://pubmed.ncbi.nlm.nih.gov/41314824/Mariana Murea, Jochen G Raimann, Jasmin Divers...
https://pubmed.ncbi.nlm.nih.gov/38943204/Wake Forest University Health Sciences
Lead Sponsor
Patient-Centered Outcomes Research Institute
Collaborating Sponsor