Incremental Hemodialysis: The TwoPlus Trial
ConditionEnd-Stage Kidney Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Hemodialysis twice weekly
- Hemodialysis thrice weekly
Treatment groups
350 Participants
are divided into 2 treatment groupsSponsors and collaborators
Wake Forest University Health Sciences
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Source ClinicalTrials.gov