Clinical Research Details

Clinical Research

The TwoPlus Study-Comparative Effectiveness of an Individualized Model of Hemodialysis vs. Conventional Hemodialysis

Study Description

The purpose of this study is to compare clinical outcomes and health-related quality of life between an individualized hemodialysis prescription and conventional hemodialysis prescription in individuals requiring chronic hemodialysis who still have residual kidney function.  

Inclusion/Exclusion Criteria

Clinical Inclusion Criteria:

1) Age ≥ 18 years 

2) New-onset kidney dysfunction requiring dialysis (also known as end-stage kidney disease [ESKD] or end-stage renal disease [ESRD] or chronic kidney disease stage 5 on dialysis [CKD5D]) started on chronic, in-center HD, or anticipated to be started on chronic, in-center HD within the next 6 weeks

3) Has received ≤18 sessions of intermittent HD (i.e., on HD for ≤6 weeks) at the time patient is approached for potential study participation

Residual Kidney Function Inclusion Criteria : 4) Kidney urea clearance ≥3.5 mL/min/1.73 m2 5) Urine volume of ≥500 mL/24 h

Exclusion Criteria:

1) Serum potassium ≥5.8 mEq/L**

2) Serum sodium ≤125 mEq/L**

3) Serum bicarbonate level ≤17 mEq/L**

4) Requirement or anticipated requirement of high-volume ultrafiltration **

5) History of medical non-adherence that, in the opinion of the site investigators and/or treating provider, precludes safe study participation

6) A medical condition that, in the opinion of the site investigators and/or treating providers, would jeopardize the safety of the participant

Open Enrollment

Contact Name: Debra Martin
Contact Phone: (904) 244-1947
Contact Email: debra.martin3@jax.ufl.edu

Investigators