Comparison of Hemodialysis Techniques in the Removal of Uremic Toxins in Chronic Renal Failure

Recruiting now

Conditions studied: Dialysis

In brief

In recent years, expanded hemodialysis has been the subject of studies, many of them done on small populations, with limited observation periods and not always unambiguous results. In the literature, there are data comparing HDx and high-flow hemodialysis in terms of small- and medium-molecule purification and control of inflammation indices; there are fewer data comparing HDx and HDF online. In contrast, there are no studies in the literature comparing HDx with HFR. With a view to personalizing therapy, demonstrating the equivalence/superiority of HDx over the other dialysis techniques under consideration could make this technique suitable precisely for that class of more malnourished and more frail patients who to date do not obtain benefits from the other methods. The objective of the study is the mid-term (12-month) evaluation and comparison of the MCO filter called Theranova 400™ (1.7 m2, steam sterilization, cut-off 25 Kda, Baxter, Heichingen, Germany) with high-flux hemodialysis (HF-HD), OL- HDF and hemodiafiltration with endogenous reinfusion (HFR) with HFR filter 17 , in combination with medical therapy under normal clinical practice, in terms of purification of low and medium molecular weight uremic toxins, control of baseline inflammatory status and erythropoietin resistance in patients with chronic renal failure undergoing hemodialysis treatment.

Key facts

Study ID

NCT06794216

Run by

IRCCS Azienda Ospedaliero-Universitaria di Bologna

People needed

50

Starts

2024-03-01

Expected to finish

2025-08-31

Last updated by the study team

2025-01-27

Who can join

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

You may qualify if…

• Age ≥18 years
• Chronic hemodialytic treatment (on dialysis for at least 6 months), hemodialytic treatment with MCO filter (Theranova) or HF filter, OL- HDF or HFR with HFR filter17.
• Continuous use of the same filter for at least 12 months.
• Diuresis < 200 ml/day.
• Trisweekly hemodialysis treatment.
• Session duration ≥ 210 minutes.
• Availability of clinical data collected during the follow-up that took place at the O.U. of Nephrology, Dialysis and Transplantation - La Manna

You may not qualify if…

• Intradialytic hypotension
• Need for dialysis without heparin
• Active bleeding
• Active hematologic diseases
• Thrombocytopenia
• Chronic hepatopathies
• Active systemic inflammatory diseases
• Uncontrolled diabetes mellitus
• Temporary vascular access
• Recurrent vascular access infections

Where it is running

• IRCCS AOU di Bologna Policlinico di Sant'Orsola — Bologna, Emilia-Romagna, Italy (enrolling)

Full record on ClinicalTrials.gov

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