Status:
RECRUITING
RandomizEd ClinicAL triaL on the Efficacy and saFety of Incremental Hemodialysis (REAL-LIFE)
Lead Sponsor:
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Collaborating Sponsors:
European Renal Association - European Dialysis and Transplant Association
Conditions:
End Stage Renal Disease on Dialysis
Eligibility:
All Genders
18+ years
Phase:
NA
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 w...
Detailed Description
The majority of dialysis patients starting hemodialysis (HD) are currently treated with a fixed dose thrice-weekly HD (3HD/wk). The 3HD/wk regimen has been assumed, until recently, almost as a dogma i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT04360694
Start Date
May 10 2021
End Date
December 31 2026
Last Update
June 12 2024
Active Locations (1)
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1
Azienda Ospedaliero Universitaria Consorziale Policlinico
Bari, Italy, 70124