Comparing Hemodiafiltration with and Without Hemoadsorption

March 10, 2025 updated by: Francisco Maduell, Hospital Clinic of Barcelona

Evaluating the Effectiveness of Combining Hemodiafiltration and Hemoadsorption in Comparison to Hemodiafiltration Alone

Goals: The aim of the study is to assess the efficacy and safety of the combination of HDF + HA compared to HDF. To do this, we will evaluate the elimination of a wide range of molecular weight molecules, including small protein-bound solutes.

Design: Prospective, single-center study. Each patient underwent two dialysis sessions with routine dialysis parameters in which HDF or HDF + HA treatment modality will be compared.

Study subjects: 20 patients, stable on a thrice-weekly hemodialysis program, will be included. Local Ethics Committee will approve the study and patients will give informed consent.

Interventions: Prospective collection of two dialysis sessions. The only difference among the sessions in each patient will be add or no sorbent cartridge. One session with FX60 Cordiax, helixone, Fresenius Medical Care in postdilution on-line hemodiafiltration and another session with the same dialyzer plus HA 130 cartridge. The order of these treatment sessions was randomly. Blood samples for analyses were taken for each patient in the same dialysis session of the week.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic of Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Adult patients (age > 18 years)
  • More than 6 months on a dialysis program
  • Stable in a hemodialysis program
  • AV fistula, prosthesis, or tunneled catheter as vascular access
  • No residual diuresis (< 200 ml/day)
  • Not enrolled in a living donor transplant program
  • No immunosuppressive treatment
  • Provide written informed consent

Exclusion Criteria

  • Chronic inflammatory diseases
  • Neoplasms
  • Immunosuppressive treatment or chronic treatment with anti-inflammatory drugs
  • Dysfunctional AV fistula or catheter
  • Single-needle dialysis
  • Kt/V less than 1.3 or PRU < 70%
  • Scheduled living donor kidney transplant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hemodiafiltration alone
Device: Hemodiafiltration
Postdilutional hemodiafiltration
Experimental: Hemodiafiltration plus hemoadsorption
Device: Hemodiafiltration
Postdilutional hemodiafiltration
Device: Hemoadsorption cartridge
HA 130 cartridge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uremic toxins reduction ratios (RR)
Time Frame: From enrollment to the end of treatment at 4-8 weeks.
Protein bound uremic toxins: p-cresyl sulfate RR, and indoxyl-sulfate RR. Medium and large molecules: ß2-microglobulin (11,800 Da) RR, myoglobin (17,200 Da) RR, kappa FLC (22,500 Da) RR, prolactin (23,000 Da) RR, α1-microglobulin (33,000 Da) RR, α1-acid glycoprotein (41,000 Da) RR, and lambda FLC (45,000 Da) RR.
From enrollment to the end of treatment at 4-8 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uremic toxins reduction ratios
Time Frame: From enrollment to the end of treatment at 4-8 weeks
Urea RR (60 Da), creatinine RR (113 Da), and albumin (66,000 Da)
From enrollment to the end of treatment at 4-8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2024

Primary Completion (Actual)

January 31, 2025

Study Completion (Actual)

February 28, 2025

Study Registration Dates

First Submitted

November 26, 2024

First Submitted That Met QC Criteria

November 26, 2024

First Posted (Actual)

November 29, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HCB/2024/0704

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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