Study Results
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Basic Information
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COMPLETED
PHASE3
50 participants
INTERVENTIONAL
2011-09-30
2013-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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standard HFR therapy
standard HFR hemodiafiltration therapy
No interventions assigned to this group
SUPRA-HFR therapy
SUPRA-HFR hemodiafiltration therapy
SUPRA-HFR
usual dialytic prescription for duration, frequency, acid buffer and anticoagulation regimen.
Interventions
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SUPRA-HFR
usual dialytic prescription for duration, frequency, acid buffer and anticoagulation regimen.
Eligibility Criteria
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Inclusion Criteria
* well functioning vascular access (QB \> 300 mL/min)
* informed consent given
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Bellco s.r.l.
UNKNOWN
Istituto Superiore di SanitÃ
OTHER
Azienda Sanitaria Locale di Cagliari
OTHER
Responsible Party
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Piergiorgio Bolasco
Head Physician
Principal Investigators
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Piergiorgio Bolasco, MD
Role: PRINCIPAL_INVESTIGATOR
Azienda Sanitaria Locale di Cagliari
Locations
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Territorial dialysis service, Regional Health system nephrology and dialysis department
Cagliari, , Italy
Nephrology and dialysis, SS. Trinità Hospital
Cagliari, , Italy
Nephrology and dialysis, Civil Hospital
La Maddalena, , Italy
Nephrology and dialysis, Civil Hospital
Lanusei, , Italy
Nephrology and dialysis department, Versilia Hospital
Lido di Camaiore, , Italy
Nephrology and dialysis department, Civil Hospital
Macomer, , Italy
Nephrology and dialysis, San Francesco Hospital
Nuoro, , Italy
Nephrology and dialysis, San Martino Hospital
Oristano, , Italy
Nephrology and dialysis department, Bonaria Hospital
San Gavino Monreale, , Italy
Nephrology and dialysis, San Camillo Hospital
Sorgono, , Italy
Nephrology and dialysis, Dettori Hospital
Tempio, , Italy
Countries
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References
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Wratten ML, Ghezzi PM. Hemodiafiltration with endogenous reinfusion. Contrib Nephrol. 2007;158:94-102. doi: 10.1159/000107239.
Bolasco PG, Ghezzi PM, Serra A, Corazza L, Murtas S, Mascia M, Cossu M, Ferrara R, Cogoni G, Cadinu F, Casu D, Contu B, Passaghe M, Ghisu T, Ganadu M, Logias F. Hemodiafiltration with endogenous reinfusion with and without acetate-free dialysis solutions: effect on ESA requirement. Blood Purif. 2011;31(4):235-42. doi: 10.1159/000322400. Epub 2011 Jan 14.
Panichi V, Manca-Rizza G, Paoletti S, Taccola D, Consani C, Filippi C, Mantuano E, Sidoti A, Grazi G, Antonelli A, Angelini D, Petrone I, Mura C, Tolaini P, Saloi F, Ghezzi PM, Barsotti G, Palla R. Effects on inflammatory and nutritional markers of haemodiafiltration with online regeneration of ultrafiltrate (HFR) vs online haemodiafiltration: a cross-over randomized multicentre trial. Nephrol Dial Transplant. 2006 Mar;21(3):756-62. doi: 10.1093/ndt/gfi189. Epub 2005 Nov 22.
Palleschi S, Ghezzi PM, Palladino G, Rossi B, Ganadu M, Casu D, Cossu M, Mattana G, Pinna AM, Contu B, Ghisu T, Monni A, Gazzanelli L, Mereu MC, Logias F, Passaghe M, Amore A, Bolasco P; Sardinian Study Group. Vitamins (A, C and E) and oxidative status of hemodialysis patients treated with HFR and HFR-Supra. BMC Nephrol. 2016 Aug 26;17(1):120. doi: 10.1186/s12882-016-0315-6.
Other Identifiers
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ASLCagliariPBolascosolismo52
Identifier Type: REGISTRY
Identifier Source: secondary_id
CRC-01
Identifier Type: -
Identifier Source: org_study_id
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