NCT06794216 Comparison of Hemodialysis Techniques in the Removal of Uremic Toxins in Chronic Renal Failure
| NCT ID | NCT06794216 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | Dialysis |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2025-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2024-03-01 with a primary completion date of 2025-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Gaetano La Manna, MD
PRINCIPAL INVESTIGATOR
IRCCS AOU di Bologna
Frequently Asked Questions
Who can join the NCT06794216 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dialysis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06794216 currently recruiting?
Yes, NCT06794216 is actively recruiting participants. Contact the research team at marcello.demetri2@unibo.it for enrollment information.
Where is the NCT06794216 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06794216 clinical trial?
NCT06794216 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The principal investigator is Gaetano La Manna, MD at IRCCS AOU di Bologna. The trial plans to enroll 50 participants.