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Incremental Hemodialysis: The TwoPlus Trial

NCT05828823 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2026-05-22

No results posted yet for this study

Summary

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.

Conditions

  • End-Stage Kidney Disease

Interventions

DEVICE

Hemodialysis twice weekly

Frequency and duration of hemodialysis is tailored to the patient. Adjuvant pharmacotherapy is prescribed to maintain volume, electrolyte and acid-base homeostasis ( e.g., diuretics, sodium bicarbonate and potassium binding patiromer)

OTHER

Hemodialysis thrice weekly

Conventional hemodialysis regimen

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Mariana Murea, MD · Wake Forest Health Sciences

  • Peter Kotanko · Renal Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-26
Primary Completion
2030-07-31
Completion
2031-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05828823 on ClinicalTrials.gov