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

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Wake Forest University Health Sciences

Criteria

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.