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

Wake Forest University (WFU) logo

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

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

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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