Actively Recruiting

Age: 18Years +
All Genders
NCT06794216

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

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-27

50

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • On chronic hemodialytic treatment for at least 6 months using MCO filter (Theranova), HF filter, OL-HDF, or HFR with HFR17 filter
  • Continuous use of the same filter for at least 12 months
  • Diuresis less than 200 ml per day
  • Undergoing trisweekly hemodialysis treatment
  • Dialysis session duration of at least 210 minutes
  • Availability of clinical data collected during follow-up at the O.U. of Nephrology, Dialysis and Transplantation - La Manna
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

IRCCS AOU di Bologna Policlinico di Sant'Orsola

Bologna, Emilia-Romagna, Italy, 40138

Actively Recruiting

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Research Team

M

Marcello Demetri, Biology

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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