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CompletedNCT02240004SUPREMOUpdated Mar 30, 2015

Hemo Filtration Reinfusion (HFR) Clearance Efficiency Towards P-bound Toxins and Effects on Inflammatory and Endothelial Damage Markers

An observational study in Inflammation, sponsored by Hospital Universitario Reina Sofia de Cordoba. Completed at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-30.

Sponsored by Hospital Universitario Reina Sofia de Cordoba · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
9
Ages
18 Years and older
Sex
All
01

Study summary

The aim of this study is to compare purification efficiency of HFR in terms of clearance of protein-bound toxins and the effects on markers of inflammation and endothelial damage, in comparison to HF-HD and OL-HDF.

Read the detailed description

Protein-bound uremic toxins are poorly removed by current dialysis techniques because of their size, which is larger than the pore size of dialysis membranes available in the market. These protein-bound uremic toxins have emerged as important risk factors for progression of CKD, as well as for cardiovascular disease. Several studies have demonstrated that protein-bound uremic toxins induce vascular inflammation, endothelial dysfunction and vascular calcification.

In dialysis patients, serum concentrations of p-cresyl sulphate and indoxyl sulphate are approximately 17 and 54 times higher, respectively, than in healthy subjects. Because these toxins are bound to proteins, only a 30% or less is removed efficiently by hemodialysis. Traditional renal replacement therapies depend upon diffusion and convection for solute clearances and the use of an adsorbent in combination with dialysis membranes may be a new therapeutic option to increase removal rate of these uremic protein-bound toxins.

HFR technique uses a dual dialyzer with a resin between chambers. The first chamber is a high-flux membrane where convective process takes place. The ultrafiltrate obtained from this first chamber passes through the cartridge and is reinfused before the second chamber, a low-flux membrane, where diffusive process is performed.

In HFR, adsorption and haemodiafiltration are attached, using ultrafiltrate as a replacement fluid and being capable of theoretically removing most medium and high molecular weight uremic toxins. A potential benefit has been regarded for toxicity, biocompatibility, tolerance, and preservation of essential elements such as albumin, vitamins, amino acids or growth factors. An improvement on oxidative stress has also been described in HFR.

02

Conditions studied

  • Inflammation

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03

In context

Inflammation

3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.

This study's enrollment of 9 is below the median of 95 across 895 observational studies indexed under Inflammation.

Browse Inflammation studies →

Lead sponsor

Hospital Universitario Reina Sofia de Cordoba is the lead sponsor of 14 studies on the registry; 1 is 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
Yes
Sampling method
Probability sample

Study population

Patients undergoing dialysis three times week

Inclusion criteria

  • Stable patients on hemodialysis for al least 3 month
  • older than 18 year old
  • dialyzed at least for two months with a high-flux membrane permeability
  • arteriovenous fistula with high blood flow (> 350 ml / min)

Exclusion criteria

Exclusion Criteria:

  • active neoplasia
  • positive viral markers (HBsAg, anti-HCV and HIV),
  • clinical signs of active infection and/or inflammation,
  • albumin \< 3.5 g/dl.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
9 participants (actual)
Patient registry
No

Interventions

  • DeviceSUPRA HFR

    usual dialytic prescription for duration, frequency, acid buffer and anticoagulation regimen

06

What researchers measure

Primary outcomes

  1. Inflammatory status: (CD14+ CD16+, CD14++ CD16+, cytokines levels)

    Time frame: 12 weeks

07

Study locations

1 site
  • HU Reina Sofia
    Cordoba, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02240004
Lead sponsor
Hospital Universitario Reina Sofia de Cordoba
Responsible party
Alejandro Martin-Malo (MD, Hospital Universitario Reina Sofia de Cordoba) — Principal investigator
First posted
Sep 15, 2014
Start date
May 2014
Primary completion
Feb 2015
Completion
Mar 2015
Last update
Mar 30, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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