A Pilot Trial of Twice-weekly Versus Thrice-weekly Hemodialysis in Patients With Incident End-stage Kidney Disease

A Randomized Pilot Study of Hemodialysis Initiation Comparing Twice-Weekly Hemodialysis Plus Dialysis-Sparing Therapy Versus Thrice-Weekly Hemodialysis (The TWOPLUS-HD Trial)

The optimal frequency of hemodialysis treatments in patients with incident end-stage kidney disease in not known. This pilot trial will randomize patients with incident end-stage kidney disease due to chronic kidney disease progression to two different regimens of hemodialysis: i) twice-weekly hemodialysis for six weeks with adjuvant pharmacologic medications followed by thrice-weekly hemodialysis, or ii) thrice-weekly hemodialysis. The study will test feasibility of stepwise hemodialysis, and the effects of the two regimens of hemodialysis on residual kidney function.

Inclusion Criteria:

• Age ≥18 years
• Incident ESKD from CKD progression (including a failing renal transplant)
• Are deemed to require dialysis initiation by the treating nephrologist
• Have elected HD for renal replacement therapy (RRT)

Exclusion Criteria:

• Have urine output <500ml per day
• Have ESKD as a result of severe acute kidney injury (AKI) (stage 3 AKI defined by Acute Kidney Injury Network [AKIN]) criteria)
• Abrupt decline in kidney function preceding HD therapy initiation (i.e., if eGFR was ≥30 mL/min/1.73 m2 3 months prior to the initiation of dialysis therapy)
• Are scheduled to undergo transplantation from a live donor within the next 6 months
• Have an active diagnosis of hepatorenal syndrome
• Have a significant malignancy that is likely to impact survival
• Have a medical condition that would jeopardize the safety of the subject.