Can we IMPROVE cardiovascular outcomes through phosphate lowering in CKD? Rationale and protocol for the IMpact of Phosphate Reduction on Vascular End-points in Chronic Kidney Disease (IMPROVE-CKD) study

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dc.contributor.authorLioufas, N.
dc.contributor.authorToussaint, N.D.
dc.contributor.authorPedagogos, E.
dc.contributor.authorElder, G.
dc.contributor.authorBadve, S.V.
dc.contributor.authorPascoe, E.
dc.contributor.authorValks, A.
dc.contributor.authorHawley, C.
dc.contributor.authorBlock, G.A.
dc.contributor.authorBoudville, N.C.
dc.contributor.authorCampbell, K.
dc.contributor.authorCameron, J.D.
dc.contributor.authorChen, S.S.M.
dc.contributor.authorFaull, R.J.
dc.contributor.authorHolt, S.G.
dc.contributor.authorHooi, L.S.
dc.contributor.authorJackson, D.
dc.contributor.authorJardine, M.J.
dc.contributor.authorJohnson, D.W.
dc.contributor.authorKerr, P.G.
dc.contributor.authoret al.
dc.date.issued2019
dc.description.abstractIntroduction: Patients with chronic kidney disease (CKD) are at heightened cardiovascular risk, which has been associated with abnormalities of bone and mineral metabolism. A deeper understanding of these abnormalities should facilitate improved treatment strategies and patient-level outcomes, but at present there are few large, randomised controlled clinical trials to guide management. Positive associations between serum phosphate and fibroblast growth factor 23 (FGF-23) and cardiovascular morbidity and mortality in both the general and CKD populations have resulted in clinical guidelines suggesting that serum phosphate be targeted towards the normal range, although few randomised and placebo-controlled studies have addressed clinical outcomes using interventions to improve phosphate control. Early preventive measures to reduce the development and progression of vascular calcification, left ventricular hypertrophy and arterial stiffness are crucial in patients with CKD. Methods and analysis: We outline the rationale and protocol for an international, multicentre, randomised parallel-group trial assessing the impact of the non-calcium-based phosphate binder, lanthanum carbonate, compared with placebo on surrogate markers of cardiovascular disease in a predialysis CKD population—the IM pact of P hosphate R eduction O n V ascular E nd-points (IMPROVE)-CKD study. The primary objective of the IMPROVE-CKD study is to determine if the use of lanthanum carbonate reduces the burden of cardiovascular disease in patients with CKD stages 3b and 4 when compared with placebo. The primary end-point of the study is change in arterial compliance measured by pulse wave velocity over a 96-week period. Secondary outcomes include change in aortic calcification and biochemical parameters of serum phosphate, parathyroid hormone and FGF-23 levels. Ethics and dissemination: Ethical approval for the IMPROVE-CKD trial was obtained by each local Institutional Ethics Committee for all 17 participating sites in Australia, New Zealand and Malaysia prior to study commencement. Results of this clinical trial will be published in peer-reviewed journals and presented at conferences.
dc.description.statementofresponsibilityNicole Lioufas, Nigel D Toussaint, Eugenia Pedagogos, Grahame Elder, Sunil V Badve, Elaine Pascoe, Andrea Valks, Carmel Hawley, Geoffrey A Block, Neil C Boudville, Katrina Campbell, James D Cameron, Sylvia S M Chen, Randall J Faull, Stephen G Holt, Lai S Hooi, Dana Jackson, Meg J Jardine, David W Johnson, Peter G Kerr, Kenneth K Lau, Alicia Morrish, Vlado Perkovic, Kevan R Polkinghorne, Carol A Pollock, Donna Reidlinger, Laura Robison, Edward R Smith, Robert J Walker, Angela Yee Moon Wang.
dc.identifier.citationBMJ Open, 2019; 9(2):e024382-1-e024382-11
dc.identifier.doi10.1136/bmjopen-2018-024382
dc.identifier.issn2044-6055
dc.identifier.issn2044-6055
dc.identifier.urihttps://hdl.handle.net/2440/134070
dc.language.isoen
dc.publisherBMJ Publishing Group
dc.relation.granthttp://purl.org/au-research/grants/nhmrc/1044302
dc.relation.granthttp://purl.org/au-research/grants/nhmrc/631731
dc.relation.granthttp://purl.org/au-research/grants/nhmrc/1092957
dc.rights© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
dc.source.urihttps://doi.org/10.1136/bmjopen-2018-024382
dc.subjectIMPROVE-CKD Writing Committee.
dc.subject.meshHumans
dc.subject.meshCardiovascular Diseases
dc.subject.meshPhosphates
dc.subject.meshLanthanum
dc.subject.meshParathyroid Hormone
dc.subject.meshFibroblast Growth Factors
dc.subject.meshClinical Protocols
dc.subject.meshDouble-Blind Method
dc.subject.meshAdult
dc.subject.meshFemale
dc.subject.meshMale
dc.subject.meshRenal Insufficiency, Chronic
dc.subject.meshHyperphosphatemia
dc.subject.meshFibroblast Growth Factor-23
dc.titleCan we IMPROVE cardiovascular outcomes through phosphate lowering in CKD? Rationale and protocol for the IMpact of Phosphate Reduction on Vascular End-points in Chronic Kidney Disease (IMPROVE-CKD) study
dc.typeJournal article
pubs.publication-statusPublished

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