Actively Recruiting
Comparison of Expanded Hemodialysis and Other Dialysis Techniques Using Theranova and HFR Filters for Toxin Removal 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
Researchers are comparing different hemodialysis techniques to understand their effectiveness in removing uremic toxins in patients with chronic renal failure. The study focuses on expanded hemodialysis (HDx) using the Theranova 400 filter compared with high-flux hemodialysis (HF-HD), online hemodiafiltration (OL-HDF), and hemodiafiltration with endogenous reinfusion (HFR). The goal is to see if HDx offers benefits, especially for more malnourished and frail patients, over other dialysis methods. This observational study analyzes data from about 50 patients treated between 2018 and 2022 at a specialized dialysis center. Patients are grouped based on the dialysis technique used: HDx with Theranova filter, HFR with HFR17 filter, OL-HDF, or HF-HD. Each group has at least 10 patients who have been on dialysis for at least six months and have used the same filter continuously for 12 months. All patients receive standard medical therapy and dialysis care as part of routine clinical practice. The study collects and compares data on the removal of small and medium molecular weight toxins, inflammation control, and erythropoietin resistance over a 12-month period. Participants' clinical data, including blood tests and relevant health events, are collected retrospectively from medical records in a pseudonymized format. No additional treatments or study-specific visits are required. Data collection and analysis will take place over approximately 18 months following ethics approval, using statistical methods to evaluate differences between dialysis methods at baseline, 3 months, and 12 months. The study monitors the safety and effectiveness of these dialysis techniques in real-world clinical settings.
CONDITIONS
Official Title
Comparison of Hemodialysis Techniques in the Removal of Uremic Toxins in Chronic Renal Failure
Who Can Participate
Eligibility Criteria
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
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
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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
Research Team
M
Marcello Demetri, Biology
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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