Protocol for the process evaluation of a randomised clinical trial of incremental-start versus conventional haemodialysis: the TwoPlus study.
Mariana Murea, Kristie L Foley, Samir C Gautam...
https://pubmed.ncbi.nlm.nih.gov/41314824Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05828823
Comparative Effectiveness of Individualized Incremental Hemodialysis Versus Conventional Hemodialysis in Patients with Kidney Dysfunction Requiring Dialysis
Led by Wake Forest University Health Sciences · Updated on 2026-05-22
350
Participants Needed
10
Research Sites
26 weeks
Total Duration
On this page
Sponsors
W
Wake Forest University Health Sciences
Lead Sponsor
P
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical effectiveness of individualized, incremental hemodialysis compared to conventional hemodialysis in patients with new onset kidney dysfunction who require dialysis and still have some residual kidney function. This study aims to see how tailored hemodialysis affects survival, hospitalizations, kidney function preservation, quality of life, fatigue, employment, and caregiver burden. It will enroll 350 patients and 140 caregivers to better understand these outcomes. Participants will be randomly assigned to one of two groups: one receiving hemodialysis twice weekly with treatment tailored based on their residual kidney function and clinical needs, including specific medications to maintain balance; the other group will receive conventional hemodialysis three times a week. Caregivers will be followed alongside patients for about two years after randomization. During the study, patients will undergo regular assessments including quality of life questionnaires, cognitive tests, caregiver burden scales, and measures of kidney function over two years. Researchers will monitor clinical safety events, hospital-free days, urine output, and recovery time after dialysis. Caregivers will also be evaluated for burden. The study's total participation lasts approximately two years with ongoing monitoring and data collection.
CONDITIONS
Brief Title
Incremental Hemodialysis: The TwoPlus Trial
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- New kidney dysfunction requiring dialysis starting or expected to start maintenance in-center hemodialysis within 12 weeks
- Received 36 or fewer intermittent hemodialysis sessions (up to 12 weeks on hemodialysis) at enrollment
- Kidney urea clearance less than 2.0 mL/min
- Urine output of 500 mL or more per 24 hours
You will not qualify if you...
- Pre-hemodialysis serum potassium level 5.8 mEq/L or higher
- Serum sodium level 125 mEq/L or lower
- Bicarbonate level 17 mEq/L or lower
- Need or expected need for high-volume ultrafiltration
- Unable or unwilling to follow study protocol
- Known pregnancy, planning pregnancy, or lactating women
- Estimated survival, dialysis modality change, or center transfer less than 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Up to 2 years
Participants receive individualized or conventional hemodialysis according to their randomized group. The frequency and duration of hemodialysis are tailored based on residual kidney function and clinical manifestations starting at twice weekly or follow the conventional thrice weekly schedule.
Regular hemodialysis visits typically 2 to 3 times per week
Trial Site Locations
Total: 10 locations
1
University of Florida
Jacksonville, Florida, United States, 32209
Actively Recruiting
2
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
Johns Hopkins University School of Medicine (JHUSM)
Baltimore, Maryland, United States, 21218
Actively Recruiting
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
5
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Actively Recruiting
6
Renal Research Institute (RRI)
New York, New York, United States, 10065
Actively Recruiting
7
Northwell Health
Queens, New York, United States, 11427
Actively Recruiting
8
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
9
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
10
University of Virginia (UVA)
Charlottesville, Virginia, United States, 22904
Actively Recruiting
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Research Team
B
Brenda Burciu
B
Ben Bagwell
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Comparative effectiveness of an individualized model of hemodialysis vs conventional hemodialysis: a study protocol for a multicenter randomized controlled trial (the TwoPlus trial).
Mariana Murea, Jochen G Raimann, Jasmin Divers...
https://pubmed.ncbi.nlm.nih.gov/38943204