NCT04360694

RandomizEd ClinicAL triaL on the Efficacy and saFety of Incremental Hemodialysis (REAL-LIFE)

Recruiting now NA Last updated 12 June 2024

What this trial tests

NA trial testing Incremental hemodialysis in End Stage Renal Disease on Dialysis in 190 participants. Currently enrolling.

Timeline

10 May 2021

Primary endpoint
31 December 2026

31 December 2026

Quick facts

Lead sponsor	Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	190
Start date	10 May 2021
Primary completion	31 December 2026
Estimated completion	31 December 2026
Sites	1 location across Italy

Drugs / interventions tested

• Incremental hemodialysis
• Conventional hemodialysis

Conditions studied

• End Stage Renal Disease on Dialysis — all drugs for End Stage Renal Disease on Dialysis →

Sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Who can join

18 and older, any sex, with End Stage Renal Disease on Dialysis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: The thrice-weekly hemodialysis (HD) regimen is widely accepted as a standard prescription. The concept of incremental dialysis has been established as a possible alternative for patients with preserved diuresis and end-stage renal failure in need of HD. The main problems related to prescription of incremental HD are an arbitrary use of infrequent regimens and the lack of clear standards for incorporating residual kidney function (RKF) in the assessment of HD dose. Several models have been proposed for prescription of incremental dialysis. The latest, the variable target model (VTM), gives more clinical weight to the RKF and allows less frequent HD treatments at lower RKF. Despite increasing evidence derived from observational studies to support the use of incremental HD, RCTs are lacking and, therefore, urgently needed.

Methods/Design:

The Department of Nephrology, Dialysis and Transplantation of the Azienda Ospedaliero Universitaria Consorziale Policlinico, Bari, Italy and the EUDIAL Working Group of the European Renal Association - European Dialysis Transplant Association (ERA-EDTA) are starting a randomized clinical trial (RCT) in incident HD patients, whose name is "REAL LIFE", by using the acronym of its whole definition: RandomizEd clinicAL triaL on the effIcacy and saFety of incremental haEmodialysis. REAL LIFE is a pragmatic, prospective, multicentre, open label RCT, investigator-initiated, comparing the intervention arm (incremental HD) with the control arm (standard 3HD/wk). The trial, originally conceived by experts at the Division of Nephrology of the Miulli General Hospital, Acquaviva delle Fonti, Italy, consists in starting the HD treatment adopting the new incremental approach guided by the VTM. The primary outcome is the survival of kidney function, with the event defined as urinary output (UO) ≤ 200 mL/day, confirmed by a further collection after 2 weeks to exclude temporary illness.

Discussion: REAL LIFE will enable the investigators to know with the highest level of scientific evidence the safety and efficacy of an incremental approach to the start of HD treatment.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Home dialysis in older adults: challenges and solutions.
   Wu HHL, Dhaygude AP, Mitra S, Tennankore KK. · · 2023 · cited 11× · PMID 36865019 · DOI 10.1093/ckj/sfac220
2. Incremental dialysis: two complementary views.
   Casino DFG, Murea M, Floege MJ, Zoccali C. · · 2024 · cited 7× · PMID 38404364 · DOI 10.1093/ckj/sfae020
3. Incremental versus standard dialysis for people with kidney failure
   Sabanayagam D, Hegerty K, Au E, Beruni N, et al · · 2023