๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-05

Incremental Hemodialysis: The TwoPlus Trial (NCT05828823)

Comparative Effectiveness of an Individualized Model of Hemodialysis Versus Conventional Hemodialysis

๐ŸŸข Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: Wake Forest University Health Sciences

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: University of Florida โ€” Jacksonville, Florida

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (10 Sites)

  • University of Florida โ€” Jacksonville, Florida
  • Emory University โ€” Atlanta, Georgia
  • Johns Hopkins University School of Medicine (JHUSM) โ€” Baltimore, Maryland
  • Massachusetts General Hospital โ€” Boston, Massachusetts
  • University of Mississippi Medical Center โ€” Jackson, Mississippi
  • Renal Research Institute (RRI) โ€” New York, New York
  • Northwell Health โ€” Queens, New York
  • University of North Carolina Chapel Hill โ€” Chapel Hill, North Carolina
  • Atrium Health Wake Forest Baptist โ€” Winston-Salem, North Carolina
  • University of Virginia (UVA) โ€” Charlottesville, Virginia

๐Ÿ“ž Contact the Study Coordinator

Phone: (336) 716-8671

Email: Brindusa.Burciu@advocatehealth.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in End-Stage Kidney Disease

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—