Comparing hemodialysis techniques for removing toxins in chronic kidney failure
Comparison of Expanded Hemodialysis With 3 Other Dialysis Techniques in the Removal of Uremic Toxins in Chronic Renal Failure
IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06794216
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 |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna (other) |
| Locations | 1 site (Bologna, Emilia-Romagna) |
| Trial ID | NCT06794216 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with active bleeding, uncontrolled diabetes, or other severe comorbidities may not benefit from this study.
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 performed: While there have been studies comparing some hemodialysis techniques, this specific comparison of HDx with HFR is novel and has not been extensively tested.
Eligibility criteria
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 this trial is running
Bologna, Emilia-Romagna
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dialysis