CClinicalTrials.gg
CompletedNCT06710834Updated Mar 13, 2025

Comparing Hemodiafiltration with and Without Hemoadsorption

An interventional study of Hemoadsorption cartridge and Hemodiafiltration in Hemodialysis, Hemodiafiltration and Hemoadsorption, sponsored by Hospital Clinic of Barcelona. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-13.

Sponsored by Hospital Clinic of Barcelona · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Hemodialysis
  • Hemodiafiltration
  • Hemoadsorption

Keywords

  • Adsorption
  • Convection
  • Hemodiafiltration
  • Efficacy
03

In context

Lead sponsor

Hospital Clinic of Barcelona is the lead sponsor of 319 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    Hemodiafiltration alone

    Device: Hemodiafiltration

  • Experimental
    Hemodiafiltration plus hemoadsorption

    Device: Hemoadsorption cartridge · Device: Hemodiafiltration

Interventions

  • DeviceHemoadsorption cartridge

    HA 130 cartridge

  • DeviceHemodiafiltration

    Postdilutional hemodiafiltration

06

What researchers measure

Primary outcomes

  1. Uremic toxins reduction ratios (RR)

    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.

    Time frame: From enrollment to the end of treatment at 4-8 weeks.

Secondary outcomes

  1. Uremic toxins reduction ratios

    Urea RR (60 Da), creatinine RR (113 Da), and albumin (66,000 Da)

    Time frame: From enrollment to the end of treatment at 4-8 weeks

07

Study locations

1 site
  • Hospital Clínic of Barcelona
    Barcelona, 08036, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06710834
Lead sponsor
Hospital Clinic of Barcelona
Responsible party
Francisco Maduell (Head of Dialysis Section, Hospital Clinic of Barcelona) — Principal investigator
First posted
Nov 29, 2024
Start date
Nov 7, 2024
Primary completion
Jan 31, 2025
Completion
Feb 28, 2025
Last update
Mar 13, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion