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

Wake Forest University (WFU)

Status and phase: Completed; Phase 3

Conditions: End Stage Renal Failure on Dialysis

Treatments: Other: Hemodialysis; Drug: Patiromer Oral Product

Study type: Interventional

Funder types: Other

Identifiers

NCT03740048

IRB00054726

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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51 participants in 2 patient groups

Hemodialysis and Pharmacologic Therapy

Experimental group

Description:

Hemodialysis regimen at the initiation of dialysis treatment: Twice-weekly hemodialysis plus adjunctive pharmacologic therapy (loop diuretic, potassium-binding agent, and sodium bicarbonate) for six consecutive weeks, continued by thrice-weekly hemodialysis (intervention group)

Treatment:

Drug: Patiromer Oral Product

Other: Hemodialysis

Conventional Hemodialysis Regimen

Active Comparator group

Description:

Hemodialysis regimen at the initiation of dialysis treatment: thrice-weekly hemodialysis

Treatment:

Other: Hemodialysis