| Title: |
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 |
| Authors: |
Lioufas, N; Toussaint, ND; Pedagogos, E; Elder, G; Badve, SV; Pascoe, E; Valks, A; Hawley, C; Block, GA; Boudville, NC; Campbell, K; Cameron, JD; Chen, SSM; Faull, RJ; Holt, SG; Hooi, LS; Jackson, D; Jardine, MJ; Johnson, DW; Kerr, PG; Lau, KK; Morrish, A; Perkovic, V; Polkinghorne, KR; Pollock, CA; Reidlinger, D; Robison, L; Smith, ER; Walker, RJ; Wang, AYM; Badve, Sunil |
| Source: |
urn:ISSN:2044-6055 ; BMJ Open, 9, 2, e024382 |
| Publisher Information: |
BMJ |
| Publication Year: |
2019 |
| Collection: |
UNSW Sydney (The University of New South Wales): UNSWorks |
| Subject Terms: |
32 Biomedical and Clinical Sciences; 3202 Clinical Sciences; Cardiovascular; Heart Disease; Prevention; Kidney Disease; Clinical Trials and Supportive Activities; Clinical Research; 6.1 Pharmaceuticals; Renal and urogenital; 3 Good Health and Well Being; Adult; Female; Humans; Male; Cardiovascular Diseases; Double-Blind Method; Fibroblast Growth Factor-23; Fibroblast Growth Factors; Hyperphosphatemia; Lanthanum; Multicenter Studies as Topic; Parathyroid Hormone; Phosphates; Randomized Controlled Trials as Topic; Renal Insufficiency; Chronic; ckd-mbd; mineral metabolism; phosphate |
| Description: |
Introduction 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 ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
unknown |
| Relation: |
https://hdl.handle.net/1959.4/unsworks_64598 |
| DOI: |
10.1136/bmjopen-2018-024382 |
| Availability: |
https://hdl.handle.net/1959.4/unsworks_64598; https://unsworks.unsw.edu.au/bitstreams/bfdee0cb-ba37-4b58-9084-6c32d4b8b245/download; https://doi.org/10.1136/bmjopen-2018-024382 |
| Rights: |
open access ; https://purl.org/coar/access_right/c_abf2 ; CC BY-NC ; https://creativecommons.org/licenses/by-nc/4.0/ ; free_to_read |
| Accession Number: |
edsbas.1F78FC7B |
| Database: |
BASE |