NCT04360694 RandomizEd ClinicAL triaL on the Efficacy and saFety of Incremental Hemodialysis (REAL-LIFE)
| NCT ID | NCT04360694 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari |
| Condition | End Stage Renal Disease on Dialysis |
| Study Type | INTERVENTIONAL |
| Enrollment | 190 participants |
| Start Date | 2021-05-10 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 190 participants in total. It began in 2021-05-10 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04360694 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying End Stage Renal Disease on Dialysis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04360694 currently recruiting?
Yes, NCT04360694 is actively recruiting participants. Contact the research team at loreto.gesualdo@uniba.it for enrollment information.
Where is the NCT04360694 trial being conducted?
This trial is being conducted at Bari, Italy.
Who is sponsoring the NCT04360694 clinical trial?
NCT04360694 is sponsored by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari. The trial plans to enroll 190 participants.