Collaborative Research on HFR High Flux (SALATO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01492491
Recruitment Status : Completed
First Posted : December 15, 2011
Last Update Posted : June 14, 2016
Bellco s.r.l.
Istituto Superiore di Sanità
Information provided by (Responsible Party):
Piergiorgio Bolasco, Azienda Sanitaria Locale di Cagliari

Brief Summary:
The purpose of this study is to evaluate the serum concentrations of antoxidant vitamines A, C, E, inflammatory cytokines and middle-large toxins in patients treated with online hemodiafiltration, standard HFR and SUPRA-HFR.

Condition or disease Intervention/treatment Phase
Inflammation Device: SUPRA-HFR Phase 3

Detailed Description:

Today, as the research work of EUTOX group highlights, large cytokines and protein-bound solutes are gaining a relevant attention because of their emerging role as mortality predictors.

Online hemodiafiltration (online HDF) has demonstrated to offer a significant depuration for small and middle toxins, but removal of protein-bound solutes is scarce. Synthetic high-flux membranes do not allow infact significant removal of molecules heavier than 15-20 KDa. Super-flux membranes may enhance online HDF convective transport but it would surely expose the patient to unacceptable losses of albumin, vitamines and aminoacids because of the non selectivity of the convective transport.

HFR is a renal replacement therapy that utilizes convection, diffusion and adsorption. It uses a double-stage filter that consists of a high-flux polyethersulfone hemofilter in the first convective stage and a low-flux polyethersulfone filter in the second diffusive stage. The stages of the filter allow complete separation of convection from diffusion. The convective part of the first stage allows pure ultrafiltrate (UF) to pass through a sorbent resin cartridge. The first convective/adsorption stage has no net fluid removal. The blood and reinfused clean UF then undergo traditional dialysis. The second stage works by classicaHD and in this final stage the weight loss occurs. HFR has demonstrated in various clinical trials to reduce the microinflammatory state with no albumin loss and minimal aminoacids losses, thanks to the high selectivity of the resin sorbent.

SUPRA-HFR is a newly developed HDF therapy based on the HFR concept scheme, which includes a super-flux membrane in the first section, coupled with an empowered resin sorbent. This should significantly enhance large solutes depuration, overcoming online HDF flaws.

Therefore we proposed a prospective, multicenter, randomized study comparing online HDF, standard HFR and SUPRA-HFR. After a wash-out stabilization period of 4 months in post-dilution online HDF, an expected number of 50 patients will be randomized either in standard HFR (25) or in SUPRA-HFR (25) and followed for 6 months. Primary end points focus on the the removal of protein-bound solutes, inflammation and nutritional state. In addition, ESAs doses and hemoglobin levels will be assessed and compared between treatment groups.

This study will provide strong evidence on the safe and clinically effective use of super-flux membranes, introduced with SUPRA-HFR therapy. It is highly likely that the outcomes of this study will affect the daily clinical practice of Italian and European dialysis centers because of the potential innovation brought to the market.

The following hypotheses will be tested:

  • SUPRA-HFR selectivity will reduce consistently the albumin, aminoacids and vitamines A, C, E losses compared to online HDF.
  • SUPRA-HFR better preservation of the nutritional parameters, coupled with the possibility to remove protein-bound toxins and cytokines should lead to a higher reduction of the microinflammatory status, compared to online HDF and to standard HFR.
  • SUPRA-HFR impact on inflammation status should ameliorate the anemia management by reducing the administered ESAs doses.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Collaborative Study on Outcome of Antioxidant Vitamines, Microinflammation Parameters and Middle-high Toxins in ESRD Patients Treated With Online HDF, HFR and SUPRA-HFR
Study Start Date : September 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : March 2013

Arm Intervention/treatment
No Intervention: standard HFR therapy
standard HFR hemodiafiltration therapy
Active Comparator: SUPRA-HFR therapy
SUPRA-HFR hemodiafiltration therapy
usual dialytic prescription for duration, frequency, acid buffer and anticoagulation regimen.

Primary Outcome Measures :
  1. selective depuration of large uraemic toxins and reduction of nutrient losses [ Time Frame: 1 year ]
    evaluation of the serum level of albumin, antioxidant vitamins and cytokines (IL6, IL1-beta)

Secondary Outcome Measures :
  1. amelioration of the anemia management [ Time Frame: 1 year ]
    evaluation of ESAs dose, Hb level

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • dialysis vintage > 6 months
  • well functioning vascular access (QB > 300 mL/min)
  • informed consent given

Exclusion Criteria:

  • polycystic kidney disease (PKD)
  • significant acute or chronic inflammatory comorbidities
  • non-renal related anemia
  • blood transfusions in the last 2 months before enrollment
  • alcohol or drugs abuse
  • malignant neoplasm
  • hemoglobinopathy or myelopathy
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01492491

Territorial dialysis service, Regional Health system nephrology and dialysis department
Cagliari, Italy, 09045
Nephrology and dialysis, SS. Trinità Hospital
Cagliari, Italy, 09132
Nephrology and dialysis, Civil Hospital
La Maddalena, Italy, 07024
Nephrology and dialysis, Civil Hospital
Lanusei, Italy, 08045
Nephrology and dialysis department, Versilia Hospital
Lido di Camaiore, Italy, 55041
Nephrology and dialysis department, Civil Hospital
Macomer, Italy, 08015
Nephrology and dialysis, San Francesco Hospital
Nuoro, Italy, 08100
Nephrology and dialysis, San Martino Hospital
Oristano, Italy, 09170
Nephrology and dialysis department, Bonaria Hospital
San Gavino Monreale, Italy, 09037
Nephrology and dialysis, San Camillo Hospital
Sorgono, Italy, 08038
Nephrology and dialysis, Dettori Hospital
Tempio, Italy, 07029
Sponsors and Collaborators
Azienda Sanitaria Locale di Cagliari
Bellco s.r.l.
Istituto Superiore di Sanità
Principal Investigator: Piergiorgio Bolasco, MD Azienda Sanitaria Locale di Cagliari

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Piergiorgio Bolasco, Head Physician, Azienda Sanitaria Locale di Cagliari Identifier: NCT01492491     History of Changes
Other Study ID Numbers: CRC-01
ASLCagliariPBolascosolismo52 ( Registry Identifier: 231152PBolasco )
First Posted: December 15, 2011    Key Record Dates
Last Update Posted: June 14, 2016
Last Verified: June 2016

Keywords provided by Piergiorgio Bolasco, Azienda Sanitaria Locale di Cagliari:
large toxins

Additional relevant MeSH terms:
Pathologic Processes