Comparing Dialysis Techniques for Removing Toxins in Kidney Failure Patients
Compares expanded hemodialysis with other dialysis methods in adults with chronic kidney failure.
Key facts
- Who runs it
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Where
- Bologna, ItalySee the site
- Trial code
- Registry title
- Comparison of Hemodialysis Techniques in the Removal of Uremic Toxins in Chronic Renal Failure
- Status
- Recruiting
- People taking part
- 50 people, planned
- Started
- 1 Mar 2024
- Planned end
- 31 Aug 2025
- Type of study
- Observational
- Record updated
- 27 January 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who have been on regular hemodialysis for chronic kidney failure and have used the same dialysis filter for at least 12 months.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Chronic kidney failure treated with hemodialysis three times a week, for at least 6 months, with urine output under 200 ml/day and sessions of 210 minutes or longer.
- Earlier treatment
- Must have used the same filter (MCO Theranova, high-flux, OL-HDF or HFR) for at least 12 months.
Main reasons for not taking part
- Low blood pressure during dialysis
- Need for dialysis without heparin
- Active bleeding
- Temporary vascular access or repeated access infections
- Active blood diseases, low platelet count, chronic liver disease, active inflammatory diseases or uncontrolled diabetes
This trial only enrols participants on dialysis. The registry sentence this rests on: 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.
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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
Who cannot take part
- Active bleeding
- Active hematologic diseases
- Active systemic inflammatory diseases
- Uncontrolled diabetes mellitus
- Recurrent vascular access infections
- Intradialytic hypotension
- Need for dialysis without heparin
- Thrombocytopenia
- Chronic hepatopathies
- Temporary vascular access
Where in Italy
- IRCCS AOU di Bologna Policlinico di Sant'OrsolaBologna, ItalyContact: Marcello Demetri, BiologyTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Comparison of Expanded Hemodialysis With 3 Other Dialysis Techniques in the Removal of Uremic Toxins in Chronic Renal Failure
- Plain-language title
- Comparing Dialysis Techniques for Removing Toxins in Kidney Failure PatientsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 27 January 2025