Comparison of Hemodialysis Techniques in the Removal of Uremic Toxins in Chronic Renal Failure

NCT06794216 | Recruiting

• 1 other identifier: EMPIRE
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Dialysis

Outcome Measures

Primary Outcomes (1)

• Difference between Dialysis' methods

  For the blood parameters of interest, taken at pre-dialysis and over the long interdialytic period at the end of dialysis during follow-up, changes will be analyzed by Wilcoxon tests (e.g., pre-dialysis uremic toxins with blood levels of the same substances at the end of dialysis or with their respective RRs) to assess the magnitude of differences found before and after dialysis. A comparison will be made between patients treated with the same dialysis technique and then a comparison with patients treated with the other methods examined considering time 0 and then at 3 and 12 months after the start of treatment with the same filter and dialysis method. The percentage of change in the medium term of erythropoietin dose and ev administered iron, the change in ERI and martial balance will be evaluated.

  Baseline (0 months), 3 months and 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

There will be about 50 patients, divided into 4 cohorts: patients undergoing HDx treatment with Theranova filter (group A), patients undergoing HFR treatment with HFR17 filter (group B), patients undergoing OL- HDF treatment (group C) and patients undergoing HD treatment with HF filter (HF HD) (group D). Each group will consist of at least 10 patients with chronic terminal kidney disease undergoing dialysis treatment at the O.U. of Nephrology, Dialysis and Transplantation, directed by Prof. Gaetano La Manna, of IRCCS AOUBO Policlinico Sant'Orsola from 01/01/2018 to 30/11/2022.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS AOU di Bologna Policlinico di Sant'Orsola

Bologna, Emilia-Romagna, 40138, Italy

RECRUITING

Study Officials

• Gaetano La Manna, MD

  IRCCS AOU di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcello Demetri, Biology

CONTACT

+393349549878; marcello.demetri2@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 27, 2025
• Study Start: March 1, 2024
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: January 27, 2025

Record last verified: 2024-12

Locations

IT (1)