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

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT03740048
Phase
PHASE3
Status
Completed

Conditions

  • End Stage Renal Failure on Dialysis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Hemodialysis — OTHER
    Hemodialysis frequency will differ in the first six weeks of hemodialysis therapy between the two treatment arms.
  • Patiromer Oral Product — DRUG
    Participants in the intervention group who develop hyperkalemia, during the first six weeks of receiving hemodialysis twice per week, will be treated with Patiromer.

Study Details

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.

Key Dates

Start date
Jun 19, 2019
Status verified
Apr 2022
Primary completion
Nov 4, 2021
Completion
Nov 4, 2021

Study Design

Enrollment
51 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Hemodialysis and Pharmacologic Therapy
    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)
  • Active Comparator: Conventional Hemodialysis Regimen
    Hemodialysis regimen at the initiation of dialysis treatment: thrice-weekly hemodialysis

Primary Outcome Measure

Patients' Adherence to Study Protocol [ Time Frame: 6 months, 12 months, 24 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest Baptist Medical CenterWinston-SalemNorth Carolina27157-

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By research site
Wake Forest Baptist Medical Center· Winston-Salem, NC

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