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Completed

NCT Number: NCT02240004

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

HU Reina Sofia

Córdoba, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

SUPRA HFR

Device

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

Primary outcomes

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

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Hospital Universitario Reina Sofia de Cordoba

Other Gov

Registry information

Official study title

Removal of Uremic Toxins and Improvement of Chronic Inflammation With HFR in Comparison With "On-Line" Hemodiafiltration and High Flux Hemodialysis.

Acronym: SUPREMO

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 15, 2014
Registry last updated
Mar 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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