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BMJ Open Is Committed to Open Peer Review. As Part of This Commitment We Make the Peer Review History of Every Article We Publish Publicly Available BMJ Open: first published as 10.1136/bmjopen-2018-024382 on 21 February 2019. Downloaded from BMJ Open is committed to open peer review. As part of this commitment we make the peer review history of every article we publish publicly available. When an article is published we post the peer reviewers’ comments and the authors’ responses online. We also post the versions of the paper that were used during peer review. These are the versions that the peer review comments apply to. The versions of the paper that follow are the versions that were submitted during the peer review process. They are not the versions of record or the final published versions. They should not be cited or distributed as the published version of this manuscript. BMJ Open is an open access journal and the full, final, typeset and author-corrected version of record of the manuscript is available on our site with no access controls, subscription charges or pay- per-view fees (http://bmjopen.bmj.com). If you have any questions on BMJ Open’s open peer review process please email [email protected] http://bmjopen.bmj.com/ on September 30, 2021 by guest. Protected copyright. BMJ Open: first published as 10.1136/bmjopen-2018-024382 on 21 February 2019. Downloaded from BMJ Open Can we IMPROVE cardiovascular outcomes through phosphate lowering in CKD? - Rationale for the IMpact of Phosphate Reduction On Vascular End-points in Chronic Kidney Disease (IMPROVE-CKD) study ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2018-024382 Article Type: Protocol Date Submitted by the Author: 24-May-2018 Complete List of Authors: Lioufas, Nicole; Royal Melbourne Hosp, Nephrology; University of Melbourne, Department of Medicine Toussaint, Nigel D.; Royal Melbourne Hosp, Nephrology; University of Melbourne, Department of Medicine Pedagogos, Eugenia; Epworth Healthcare Elder, Grahame; Westmead Hospital, Department of Renal Medicine; Garvan Institute of Medical Research, Osteoporosis and Bone Biology Division Badve, Sunil; St. George Hospital, Department of Nephrology Pascoe, Elaine; University of Queensland, Faculty of Medicine; Australasian http://bmjopen.bmj.com/ Kidney Trials Network Valks, Andrea; Australasian Kidney Trials Network Hawley, Carmel; The University of Queensland, Faculty of Medicine; Princess Alexandra Hospital, Department of Nephrology phosphate, mineral metabolism, randomized controlled trial, CKD-MBD, Keywords: pulse wave velocity, vascular calcification on September 30, 2021 by guest. Protected copyright. For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open: first published as 10.1136/bmjopen-2018-024382 on 21 February 2019. Downloaded from Page 1 of 40 BMJ Open 1 1 2 3 th 4 24 May 2018 5 6 7 Dr Trish Groves 8 9 Editor-in-Chief, BMJ Open 10 11 BMJ Open Editorial Office, BMA House 12 13 Tavistock Square, London, WC1H 9JR, UK 14 15 16 For peer review only 17 18 19 Dear Dr Groves, 20 21 We would like to submit the attached manuscript “Can we IMPROVE cardiovascular 22 23 outcomes through phosphate lowering in CKD? - Rationale for the IMpact of Phosphate 24 25 Reduction On Vascular End-points in Chronic Kidney Disease (IMPROVE-CKD) study” for 26 27 publication in BMJ Open. We believe this is an important manuscript because of the paucity 28 29 of clinical trials assessing the benefits of treating hyperphosphatemia in patients with chronic 30 31 http://bmjopen.bmj.com/ 32 kidney disease (CKD), despite this management being common clinical practice based on 33 34 numerous experimental and observational studies suggesting phosphate imbalance as a 35 36 cardiovascular risk factor. This manuscript outlines the rationale and protocol for an 37 38 international, multi-centre, placebo-controlled randomized trial in pre-dialysis CKD patients 39 on September 30, 2021 by guest. Protected copyright. 40 currently being conducted and this paper has not been submitted for publication elsewhere. 41 42 43 44 45 Yours sincerely, 46 47 48 49 50 Associate Professor Nigel Toussaint 51 52 Department of Nephrology, The Royal Melbourne Hospital 53 54 Grattan Street, Parkville, Victoria 3052, Australia. 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open: first published as 10.1136/bmjopen-2018-024382 on 21 February 2019. Downloaded from BMJ Open Page 2 of 40 2 1 2 3 4 Title page 5 6 7 8 9 10 Can we IMPROVE cardiovascular outcomes through phosphate lowering 11 12 13 in CKD? - Rationale for the IMpact of Phosphate Reduction On Vascular 14 15 End-points in Chronic Kidney Disease (IMPROVE-CKD) study 16 For peer review only 17 18 19 20 21 Nicole LIOUFAS*1,2, Nigel D TOUSSAINT*1,2, Eugenia PEDAGOGOS2,3, Grahame J 22 23 ELDER4,5, Sunil V BADVE6, Elaine M PASCOE7,8, Andrea VALKS7,8, Carmel M 24 25 HAWLEY7,8,9, on behalf of the IMPROVE-CKD Writing Committee. 26 27 28 1Department of Nephrology, The Royal Melbourne Hospital, Parkville, Australia, 29 30 2Department of Medicine (RMH), University of Melbourne, Parkville, Australia, 3Epworth 31 http://bmjopen.bmj.com/ 32 4 33 HealthCare, Melbourne, Australia, Department of Renal Medicine, Westmead Hospital, 34 5 35 Westmead, Australia, Osteoporosis and Bone Biology Division, Garvan Institute of Medical 36 6 37 Research, Darlinghurst, Australia, Department of Nephrology, St. George Hospital, Sydney, 38 39 Australia, 7Faculty of Medicine, University of Queensland, Woolloongabba, Australia, on September 30, 2021 by guest. Protected copyright. 40 41 8Australasian Kidney Trials Network, Brisbane, Australia, 9Department of Nephrology, 42 43 Princess Alexandra Hospital, Woolloongabba, Australia. 44 45 46 * Co-primary authors 47 48 49 Running head: IMPROVE-CKD study 50 51 52 Word count: Abstract 287 Text 3584 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open: first published as 10.1136/bmjopen-2018-024382 on 21 February 2019. Downloaded from Page 3 of 40 BMJ Open 3 1 2 3 4 Correspondence: Associate Professor Nigel Toussaint 5 6 Department of Nephrology, The Royal Melbourne Hospital, 7 8 Grattan Street, Parkville, Victoria 3052, Australia. 9 10 E-mail: [email protected] 11 12 13 14 15 Keywords: arterial compliance, cardiovascular disease, chronic kidney disease, chronic 16 For peer review only 17 kidney disease mineral and bone disorder (CKD-MBD), phosphate, vascular calcification 18 19 20 21 22 23 24 25 26 27 28 29 30 31 http://bmjopen.bmj.com/ 32 33 34 35 36 37 38 39 on September 30, 2021 by guest. Protected copyright. 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open: first published as 10.1136/bmjopen-2018-024382 on 21 February 2019. Downloaded from BMJ Open Page 4 of 40 4 1 2 3 4 IMPROVE-CKD investigators: 5 6 7 Nigel D Toussaint, The Royal Melbourne Hospital, Parkville, Victoria, Australia 8 Eugenia Pedagogos, Epworth Healthcare, Melbourne, Victoria, Australia 9 10 Nicole Lioufas, The Royal Melbourne Hospital, Parkville, Victoria, Australia 11 Carmel M Hawley, Princess Alexandra Hospital, Brisbane, Queensland, Australia 12 Grahame J Elder, Westmead Hospital, Westmead, New South Wales, Australia 13 14 Elaine M Pascoe, Australasian Kidney Trials Network, Brisbane, Australia 15 Andrea Valks, Australasian Kidney Trials Network, Brisbane, Australia 16 For peer review only 17 Sunil V Badve, St. George Hospital, Sydney, New South Wales, Australia 18 Geoffrey A Block, Colorado Kidney Care, Denver, United States 19 20 Neil C Boudville, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia; and 21 University of Western Australia, Perth, Western Australia, Australia 22 23 Katrina Campbell, Princess Alexandra Hospital, Brisbane, Queensland, Australia 24 James D Cameron, Monash Medical Centre, Clayton, Victoria, Australia 25 26 Sylvia Chen, Epworth Healthcare, Melbourne, Victoria, Australia 27 Randall J Faull, Royal Adelaide Hospital, Adelaide, South Australia, Australia 28 29 Stephen G Holt, The Royal Melbourne Hospital, Parkville, Victoria, Australia 30 Lai S Hooi, Sultanah Aminah Hospital, Johor Bahru, Malaysia 31 http://bmjopen.bmj.com/ 32 Dana Jackson, Monash Medical Centre, Clayton, Victoria, Australia 33 Meg J Jardine, Concord Hospital, Sydney, New South Wales, Australia 34 35 David W Johnson, Princess Alexandra Hospital, Brisbane, Queensland, Australia; and 36 University of Queensland, Brisbane, Queensland, Australia 37 38 Peter G Kerr, Monash Medical Centre, Clayton, Victoria, Australia 39 Kenneth K Lau, Monash Medical Centre, Clayton, Victoria, Australia on September 30, 2021 by guest. Protected copyright. 40 41 Alicia Morrish, Australasian Kidney Trials Network, Brisbane, Australia 42 Vlado Perkovic, The George Institute, Sydney, New South Wales, Australia 43 44 Kevan R Polkinghorne, Monash Medical Centre, Clayton, Victoria, Australia 45 Carol A Pollock, Royal North Shore Hospital, Sydney, New South Wales, Australia 46 47 Donna Reidlinger, Australasian Kidney Trials Network, Brisbane, Australia 48 Laura Robison, Australasian Kidney Trials Network, Brisbane, Australia 49 50 Edward R Smith, The Royal Melbourne Hospital, Parkville, Victoria, Australia 51 Robert J Walker, Dunedin Hospital, Dunedin, New Zealand 52 53 Angela Yee Moon Wang, University of Hong Kong, Queen Mary Hospital, Hong Kong 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open: first published as 10.1136/bmjopen-2018-024382 on 21 February 2019. Downloaded from Page 5 of
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