Collaborative Research on HFR High Flux (SALATO)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by ASL Cagliari.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Bellco s.r.l.
Istituto Superiore di Sanità
Information provided by (Responsible Party):
Piergiorgio Bolasco, ASL Cagliari
ClinicalTrials.gov Identifier:
NCT01492491
First received: December 10, 2011
Last updated: December 14, 2011
Last verified: December 2011
  Purpose

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 Intervention Phase
Inflammation
Device: SUPRA-HFR
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by ASL Cagliari:

Primary Outcome Measures:
  • selective depuration of large uraemic toxins and reduction of nutrient losses [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    evaluation of the serum level of albumin, antioxidant vitamins and cytokines (IL6, IL1-beta)


Secondary Outcome Measures:
  • amelioration of the anemia management [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    evaluation of ESAs dose, Hb level


Estimated Enrollment: 50
Study Start Date: September 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: standard HFR therapy
standard HFR hemodiafiltration therapy
Active Comparator: SUPRA-HFR therapy
SUPRA-HFR hemodiafiltration therapy
Device: SUPRA-HFR
usual dialytic prescription for duration, frequency, acid buffer and anticoagulation regimen.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01492491

Contacts
Contact: Piergiorgio Bolasco, MD pg.bolasco@tin.it
Contact: Vincenzo Panichi, MD v.panichi@usl12.toscana.it

Locations
Italy
Territorial dialysis service, Regional Health system nephrology and dialysis department Recruiting
Cagliari, Italy, 09045
Contact: Piergiorgio Bolasco, MD       pg.bolasco@tin.it   
Principal Investigator: Piergiorgio Bolasco, MD         
Nephrology and dialysis, SS. Trinità Hospital Recruiting
Cagliari, Italy, 09132
Contact: Alessandro Monni, MD       trinita.dialisi@tiscali.it   
Principal Investigator: Alessandro Monni, MD         
Nephrology and dialysis, Civil Hospital Recruiting
La Maddalena, Italy, 07024
Contact: Luana Gazzanelli, MD       l.gazzanelli@virgilio.it   
Principal Investigator: Luana Gazzanelli, MD         
Nephrology and dialysis, Civil Hospital Recruiting
Lanusei, Italy, 08045
Contact: Bruno Contu, MD       dialisi.lanusei@tiscali.it   
Principal Investigator: Bruno Contu, MD         
Nephrology and dialysis department, Versilia Hospital Recruiting
Lido di Camaiore, Italy, 55041
Contact: Vincenzo Panichi, MD       vpanichi@med.unipi.it   
Principal Investigator: Vincenzo Panichi, MD         
Nephrology and dialysis department, Civil Hospital Recruiting
Macomer, Italy, 08015
Contact: Tonina Ghisu, MD       dialisimacomer@tiscali.it   
Principal Investigator: Tonina Ghisu, MD         
Nephrology and dialysis, San Francesco Hospital Recruiting
Nuoro, Italy, 08100
Contact: Franco Cadinu, MD       nefrologianuoro@aslnuoro.it   
Principal Investigator: Franco Cadinu, MD         
Nephrology and dialysis, San Martino Hospital Recruiting
Oristano, Italy, 09170
Contact: Maria A Sechi, MD       aslornefro@tiscali.it   
Principal Investigator: Maria A Sechi, MD         
Nephrology and dialysis department, Bonaria Hospital Recruiting
San Gavino Monreale, Italy, 09037
Contact: Maria C Mereu, MD       mariacristina.mereu@asl6sanluri.it   
Principal Investigator: Maria C Mereu, MD         
Nephrology and dialysis, San Camillo Hospital Recruiting
Sorgono, Italy, 08038
Contact: Franco Logias, MD       logias@tiscali.it   
Principal Investigator: Franco Logias, MD         
Nephrology and dialysis, Dettori Hospital Recruiting
Tempio, Italy, 07029
Contact: Giovanni M Passaghe       dialisi.tempio@tiscali.it   
Principal Investigator: Giovanni M Passaghe, MD         
Sponsors and Collaborators
ASL Cagliari
Bellco s.r.l.
Istituto Superiore di Sanità
Investigators
Principal Investigator: Piergiorgio Bolasco, MD ASL Cagliari