NCT01492491

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 15, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

June 14, 2016

Status Verified

June 1, 2016

Enrollment Period

1.3 years

First QC Date

December 10, 2011

Last Update Submit

June 13, 2016

Conditions

Inflammation

Keywords

SUPRA-HFRadsorpitionvitaminslarge toxins

Outcome Measures

Primary Outcomes (1)

  • selective depuration of large uraemic toxins and reduction of nutrient losses

    evaluation of the serum level of albumin, antioxidant vitamins and cytokines (IL6, IL1-beta)

    1 year

Secondary Outcomes (1)

  • amelioration of the anemia management

    1 year

Study Arms (2)

standard HFR therapy

NO INTERVENTION

standard HFR hemodiafiltration therapy

SUPRA-HFR therapy

ACTIVE COMPARATOR

SUPRA-HFR hemodiafiltration therapy

Device: SUPRA-HFR

Interventions

SUPRA-HFRDEVICE

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

SUPRA-HFR therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Territorial dialysis service, Regional Health system nephrology and dialysis department

Cagliari, 09045, Italy

Location

Nephrology and dialysis, SS. Trinità Hospital

Cagliari, 09132, Italy

Location

Nephrology and dialysis, Civil Hospital

La Maddalena, 07024, Italy

Location

Nephrology and dialysis, Civil Hospital

Lanusei, 08045, Italy

Location

Nephrology and dialysis department, Versilia Hospital

Lido di Camaiore, 55041, Italy

Location

Nephrology and dialysis department, Civil Hospital

Macomer, 08015, Italy

Location

Nephrology and dialysis, San Francesco Hospital

Nuoro, 08100, Italy

Location

Nephrology and dialysis, San Martino Hospital

Oristano, 09170, Italy

Location

Nephrology and dialysis department, Bonaria Hospital

San Gavino Monreale, 09037, Italy

Location

Nephrology and dialysis, San Camillo Hospital

Sorgono, 08038, Italy

Location

Nephrology and dialysis, Dettori Hospital

Tempio, 07029, Italy

Location

Related Publications (4)

  • Wratten ML, Ghezzi PM. Hemodiafiltration with endogenous reinfusion. Contrib Nephrol. 2007;158:94-102. doi: 10.1159/000107239.

    PMID: 17684347BACKGROUND

  • 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.

    PMID: 21242676BACKGROUND

  • 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.

    PMID: 16303780BACKGROUND

  • 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.

    PMID: 27566671DERIVED

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Piergiorgio Bolasco, MD

    Azienda Sanitaria Locale di Cagliari

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Physician

Study Record Dates

First Submitted

December 10, 2011

First Posted

December 15, 2011

Study Start

September 1, 2011

Primary Completion

December 1, 2012

Study Completion

March 1, 2013

Last Updated

June 14, 2016

Record last verified: 2016-06

Locations

IT(11)