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The Omega-3 fatty acids (Fish Oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) study: the updated final trial protocol and rationale of post-initiation trial modifications

Viecelli AK 1 , Pascoe E 2 , Polkinghorne KR 3 , Hawley C 4 , Paul-Brent PA 5 , Badve SV 6 Show all authors , Cass A 7 , Heritier S 8 , Kerr PG 9 , Mori TA 10 , Robertson A 11 , Seong HL 12 , Irish AB 13 , FAVOURED study team

Affiliations 

  • 1 Department of Nephrology, Princess Alexandra Hospital, Brisbane, QLD, Australia. andrea.viecelli@health.qld.gov.au
  • 2 Australasian Kidney Trials Network, School of Medicine, University of Queensland, Brisbane, QLD, Australia. e.pascoe@uq.edu.au
  • 3 Department of Nephrology, Monash Medical Centre, Melbourne, VIC, Australia. kevan.polkinghorne@monash.edu
  • 4 Department of Nephrology, Princess Alexandra Hospital, Brisbane, QLD, Australia. carmel.hawley@health.qld.gov.au
  • 5 Australasian Kidney Trials Network, School of Medicine, University of Queensland, Brisbane, QLD, Australia. p.kerr@uq.edu.au
  • 6 Department of Nephrology, Princess Alexandra Hospital, Brisbane, QLD, Australia. sunil.badve@health.qld.gov.au
  • 7 Menzies School of Health Research, Charles Darwin University, Darwin, Australia. alan.cass@menzies.edu.au
  • 8 Department of Epidemiology, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia. Stephane.Heritier@monash.edu
  • 9 Department of Nephrology, Monash Medical Centre, Melbourne, VIC, Australia. Peter.Kerr@monash.edu
  • 10 School of Medicine and Pharmacology, University of Western Australia, Perth, WA, Australia. trevor.mori@uwa.edu.au
  • 11 Department of Surgery, Royal Melbourne Hospital, Melbourne, VIC, Australia. Amanda.Robertson@mh.org.au
  • 12 Hospital Sultanah Aminah, Johor Bahru, Malaysia. laihooi@pd.jaring.my
  • 13 School of Medicine and Pharmacology, University of Western Australia, Perth, WA, Australia. ashley.irish@health.wa.gov.au
BMC Nephrol, 2015;16:89.
PMID: 26116581 DOI: 10.1186/s12882-015-0089-2

Abstract

The FAVOURED study is an international multicentre, double-blind, placebo-controlled trial which commenced recruitment in 2008 and examines whether omega-3 polyunsaturated fatty acids (omega-3 PUFAs) either alone or in combination with aspirin will effectively reduce primary access failure of de novo arteriovenous fistulae (AVF) in patients with stage 4 and 5 chronic kidney disease. Publication of new evidence derived from additional studies of clopidogrel and a high screen failure rate due to prevalent aspirin usage prompted an updated trial design.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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