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

Recruiting now · Not applicable

Conditions studied: End Stage Renal Disease on Dialysis

In brief

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.

Key facts

Study ID

NCT04360694

Run by

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

People needed

190

Starts

2021-05-10

Expected to finish

2026-12-31

Last updated by the study team

2024-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults aged > 18 years
• Start of maintenance hemodialysis treatment due to advanced CKD stage 5D
• Patients who are about to start HD or have already started HD within a period of ≤ 2 weeks
• Glomerular filtration rate <= 10 mL/min/1.73 m2, as estimated by means of CKD-EPI formula.

You may not qualify if…

• Age < 18 years
• Acute kidney injury or acute on chronic kidney injury
• eGFR higher than 10 mL/min/1.73 m2
• UO < 600 mL/day
• Already treated with other replacement therapies (peritoneal dialysis or kidney transplant)
• Unable or unwilling to give informed consent.
• Unable to comply with trial procedures, e.g., collection of UO.
• Likely survival prognosis or planned modality or centre transfer < 6 months.
• Patients who are in the waiting list for a living kidney transplant
• Associated diseases: active neoplastic disease; refractory congestive heart failure (type IV NYHA, ejection fraction ≤ 30%) requiring high ultrafiltration volumes per session.

Where it is running

• Azienda Ospedaliero Universitaria Consorziale Policlinico — Bari, Italy (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.