Comparing hemodialysis techniques for removing toxins in chronic kidney failure
Official title: Comparison of Expanded Hemodialysis With 3 Other Dialysis Techniques in the Removal of Uremic Toxins in Chronic Renal Failure
Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06794216 · Data updated 2026-11-12
This study is trying to see if a new hemodialysis filter can remove more toxins from patients with chronic kidney failure compared to other standard methods.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna, Emilia-Romagna) |
| Status | Recruiting |
| Started | March 1, 2024 |
| Main results expected | August 31, 2025 |
| Study ends | August 31, 2025 |
| Registry record updated | January 27, 2025 |
| Trial ID | NCT06794216 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who have been on chronic hemodialysis for at least six months and meet specific clinical criteria.
✕Probably not a fit
Patients with active bleeding, uncontrolled diabetes, or other severe comorbidities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study evaluates the effectiveness of different hemodialysis techniques in removing uremic toxins from patients with chronic end-stage renal disease. It compares the Theranova 400™ filter used in expanded hemodialysis (HDx) with high-flux hemodialysis (HF HD), online hemodiafiltration (OL-HDF), and high-flux hemodiafiltration (HFR). The study will analyze data from approximately 50 patients treated over a four-year period, focusing on mid-term outcomes and the potential benefits of personalized therapy for frail patients. The study is non-interventional, relying on standard clinical practices and existing patient data.
Why it matters
Potential benefit: If successful, this study could lead to improved dialysis techniques that better remove toxins and enhance the quality of life for patients with chronic kidney failure.
How similar studies have gone: While there have been studies comparing some hemodialysis techniques, this specific comparison of HDx with HFR is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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's running
-
IRCCS AOU di Bologna Policlinico di Sant'Orsola
Bologna, Emilia-Romagna, Italy Recruiting
Study contacts
- Principal investigator: Gaetano La Manna, MD — IRCCS AOU di Bologna
- Study coordinator: Marcello Demetri, Biology
- Email: marcello.demetri2@unibo.it
- Phone: +393349549878
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.