NCT05828823

Incremental Hemodialysis: The TwoPlus Trial

Comparative Effectiveness of an Individualized Model of Hemodialysis Versus Conventional Hemodialysis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will analyze the effects of differentiated care with individualized hemodialysis on patient health related quality of life, fatigue, employment, and caregiver burden in patients with Kidney dysfunction requiring dialysis (KDRD) and appreciable kidney function. This study will compare the outcomes in survival, hospitalization, preservation of the kidney function and quality of life between hemodialysis tailored to each patient needs (incremental) and conventional hemodialysis.

Conditions

• End-Stage Kidney Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-02-26
• Primary completion: 2027-09-01
• Completion: 2028-03-01
• First posted: 2023-04-25
• Last updated: 2026-01-29

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study