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. 2019 Dec 6;5(2):135–148. doi: 10.1016/j.ekir.2019.11.014

Table 2.

Summary of randomized pilot trials in the study of less frequent hemodialysis

Principal investigator(s),
study,
N = planned participant enrollment (per arm)
Intervention arm Comparator arm Key enrollment criteria Primary Outcome Country and date of application Clinical Trial Registry number
Diera et al.105
Incremental Hemodialysis in Incident Patients (IHDIP)
N = 75
Once-weekly HD. The number of HD sessions per week is increased to 2 and later to 3 per criteria for progression. Thrice-weekly HD
  • Age ≥18 yr

  • CKD stage 5

  • KrU ≥ 4 ml/min per 1.73 m2

Patient survival Spain,
August 2017
NCT03239808
Fernándex and Teruel106
Incremental Hemodialysis as a Starting Way of Renal Replacement Therapy
N = 42
Twice-weekly HD Thrice-weekly HD
  • Kru ≥ to 2.5 ml/min

  • Urine output: nonanuric

Change in RKF Spain,
October 2017
NCT03302546
Vilar107
Incremental HD
N = 25
Twice-weekly HD. The dialysis dose is adjusted according to measurement of RKF. Thrice-weekly HD
  • Age ≥18 yr

  • HD vintage ≤3 mo

  • Kru ≥3 ml/min per 1.73m2

Feasibility United Kingdom,
February 2018
NCT03418181
Murea108
The TWOPLUS-HD Pilot Trial
N = 101
Twice-weekly HD for 6 wk plus adjuvant pharmacologic therapy (diuretics, potassium binder, sodium bicarbonate) followed by thrice-weekly HD. Thrice-weekly HD
  • Age ≥18 yr

  • ESKD due to CKD progression

  • HD vintage ≤7 d

  • Urine output ≥500 ml/d

Feasibility North Carolina, USA,
November 2018
NCT03740048
White109
Dialysis-Less Frequently In The Elderly (D-LITE)
N = 20
Twice-weekly HD Thrice-weekly HD
  • Age ≥70 yr

  • Incident ESKD and survived on HD ≥7 wk

Feasibility Canada,
December 2018
NCT03787719
Sirich110
Efficacy of Twice Weekly Hemodialysis in Patients With Residual Kidney Function
N = 25
Twice-weekly HD for 4 wk, cross-over design Thrice-weekly HD for 4 wk; cross-over design
  • Kru ≥ 2.5 ml/min

Kidney disease−related QoL California, USA,
March 2019
NCT03874117

CKD, chronic kidney disease; ESKD, end-stage kidney disease; HD, hemodialysis; Kru, residual renal urea clearance measured by timed urine collection; QoL, quality of life; RKF, residual kidney function.