Corresponding Author: Hiroaki Ogata, MD, Division of Nephrology, Department of Internal Medicine, Showa University Northern Yokohama Hospital, Chigasaki-chuo 35-1, Tsuzuki, Yokohama 224-8503, Kanagawa, Japan (firstname.lastname@example.org).
Accepted for Publication: March 12, 2021.
Author Contributions: Dr Kagimura had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Fukagawa, Hirakata, Akizawa.
Acquisition, analysis, or interpretation of data: Ogata, Hirakata, Kagimura, Fukushima, Akizawa.
Drafting of the manuscript: Ogata, Kagimura.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Kagimura.
Obtained funding: Hirakata, Akizawa.
Supervision: Ogata, Fukagawa, Hirakata, Fukushima, Akizawa.
Conflict of Interest Disclosures: Dr Ogata reported receiving lecture fees from Bayer Yakuhin, Kyowa Kirin, Torii Pharmaceutical, Otsuka, Kissei Pharmaceutical, Mitsubishi Tanabe Pharma, Sumitomo Dainippon Pharm, Daiichi Sankyo, Kowa, Ono Pharmaceutical; grants from Torii Pharmaceutical and Ono Pharmaceutical; and consulting fees from YL Biologics. Dr Fukagawa reported receiving personal fees from Bayer Yakuhin and grants from Kyowa Kirin. Dr Hirakata reported receiving personal fees from Kyowa-Kirin, Chugai Pharma, Torii, Japan Tobacco, and Ono Yakuhin. Dr Kagimura reported receiving grants from Bayer Yakuhin. Dr Akizawa reported receiving consulting and lecture fees from Bayer Yakuhin, Astellas, Kyowa Kirin, Kissei Pharmaceutical, Ono Pharmaceutical, Fuso Pharmaceutical Industry, Torii Pharmaceutical; consulting fees from GlaxoSmithKline, JT Pharmaceutical, Nipro Corporation, Otsuka, and Sanwa Chemical; and lecture fees from Chugai Pharmaceutical. No other disclosures were reported.
Funding/Support: This trial was funded by Bayer Yakuhin Ltd.
Role of the Funder/Sponsor: Bayer Yakuhin Ltd had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. However, the company was kept informed of the progress of the study. There were no confidentiality agreements regarding the data.
Group Information: the LANDMARK Investigators and Committees appear in Supplement 4.
Meeting Presentation: Presented at the American Society of Nephrology Annual Kidney Week meeting, October 27, 2018, San Diego, California.
Data Sharing Statement: See Supplement 5.
Additional Contribution: Editorial support, in the form of medical writing, assembling tables, and creating high-resolution images based on authors’ detailed directions, collating author comments, copyediting, fact-checking, and referencing, was provided by Editage, Cactus Communications, and funded by the Department of Internal Medicine, Showa University Northern Yokohama Hospital.
SK , Stack
AG , Levin
NW , Hulbert-Shearon
T , Port
FK . Association of elevated serum PO(4), Ca x PO(4) product, and parathyroid hormone with cardiac mortality risk in chronic hemodialysis patients. J Am Soc Nephrol
. 2001;12(10):2131-2138.PubMedGoogle ScholarCrossref
F , Blayney
MJ , Albert
et al. Mortality risk for dialysis patients with different levels of serum calcium, phosphorus, and PTH: the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis
. 2008;52(3):519-530. doi:10.1053/j.ajkd.2008.03.020PubMedGoogle ScholarCrossref
AP , de Lusignan
S , van Vlymen
et al. Serum phosphate as a risk factor for cardiovascular events in people with and without chronic kidney disease: a large community based cohort study. PLoS One
. 2013;8(9):e74996. doi:10.1371/journal.pone.0074996PubMedGoogle Scholar
J , Kim
J , Ireland
et al; ARO Investigators. Serum iPTH, calcium and phosphate, and the risk of mortality in a European haemodialysis population. Nephrol Dial Transplant
. 2011;26(6):1948-1955. doi:10.1093/ndt/gfq219PubMedGoogle ScholarCrossref
T , Kobayashi
S , Oka
et al. Lanthanum carbonate delays progression of coronary artery calcification compared with calcium-based phosphate binders in patients on hemodialysis: a pilot study. J Cardiovasc Pharmacol Ther
. 2013;18(5):439-446. doi:10.1177/1074248413486355PubMedGoogle ScholarCrossref
C , Wang
S , Zhao
S , Zhang
X . Effect of lanthanum carbonate on coronary artery calcification and bone mineral density in maintenance hemodialysis patients with diabetes complicated with adynamic bone disease: a prospective pilot study. Medicine (Baltimore)
. 2017;96(45):e8664. doi:10.1097/MD.0000000000008664PubMedGoogle Scholar
Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group. KDIGO 2017 clinical practice guideline update for the diagnosis, evaluation, prevention, and treatment of chronic kidney disease-mineral and bone disorder (CKD-MBD). Kidney Int Suppl (2011)
. 2017;7(1):1-59. doi:10.1016/j.kisu.2017.04.001PubMedGoogle ScholarCrossref
J , Paik
JM , Tsacogianis
T , Kim
SC , Schneeweiss
S , Desai
RJ . Cardiovascular outcomes of calcium-free vs calcium-based phosphate binders in patients 65 years or older with end-stage renal disease requiring hemodialysis. JAMA Intern Med
. 2019;179(6):741-749. doi:10.1001/jamainternmed.2019.0045PubMedGoogle ScholarCrossref
M , Yokoyama
K , Koiwa
et al; CKD-MBD Guideline Working Group; Japanese Society for Dialysis Therapy. Clinical practice guideline for the management of chronic kidney disease-mineral and bone disorder. Ther Apher Dial
. 2013;17(3):247-288. doi:10.1111/1744-9987.12058PubMedGoogle ScholarCrossref
GA , Wheeler
DC , Persky
et al. Effects of phosphate binders in moderate CKD. J Am Soc Nephrol
. 2012;23(8):1407-1415. PubMedGoogle ScholarCrossref
B , Bellasi
A , Russo
D ; INDEPENDENT Study Investigators. Mortality in kidney disease patients treated with phosphate binders: a randomized study. Clin J Am Soc Nephrol
. 2012;7(3):487-493. doi:10.2215/CJN.03820411PubMedGoogle ScholarCrossref
B , Molony
D , Bell
et al; INDEPENDENT Study Investigators. Sevelamer versus calcium carbonate in incident hemodialysis patients: results of an open-label 24-month randomized clinical trial. Am J Kidney Dis
. 2013;62(4):771-778. doi:10.1053/j.ajkd.2013.03.023PubMedGoogle ScholarCrossref
GA , Raggi
P , Bellasi
A , Kooienga
L , Spiegel
DM . Mortality effect of coronary calcification and phosphate binder choice in incident hemodialysis patients. Kidney Int
. 2007;71(5):438-441. doi:10.1038/sj.ki.5002059PubMedGoogle ScholarCrossref
GM , Raggi
P , Chasan-Taber
S , Bommer
J , Holzer
H , Burke
SK . Determinants of progressive vascular calcification in haemodialysis patients. Nephrol Dial Transplant
. 2004;19(6):1489-1496. PubMedGoogle ScholarCrossref
P , Chertow
GM , Torres
et al; ADVANCE Study Group. The ADVANCE study: a randomized study to evaluate the effects of cinacalcet plus low-dose vitamin D on vascular calcification in patients on hemodialysis. Nephrol Dial Transplant
. 2011;26(4):1327-1339. doi:10.1093/ndt/gfq725PubMedGoogle ScholarCrossref
H , Fukagawa
M , Hirakata
HN , Kagimura
T , Akizawa
T . Comparison of lanthanum carbonate with calcium carbonate for the progression of coronary artery calcification in hemodialysis. Abstract. J Am Soc Nephrol
. 2017;28:B7.Google ScholarCrossref
DA , Bragg-Gresham
JL , Koenig
et al. Association of comorbid conditions and mortality in hemodialysis patients in Europe, Japan, and the United States: the Dialysis Outcomes and Practice Patterns Study (DOPPS). J Am Soc Nephrol
. 2003;14(12):3270-3277. doi:10.1097/01.ASN.0000100127.54107.57PubMedGoogle ScholarCrossref
HA , Karaboyas
A , Cizman
et al. Cardiovascular event rates among hemodialysis patients across geographical regions—a Snapshot from the Dialysis Outcomes and Practice Patterns Study (DOPPS). Kidney Int Rep
. 2019;4(6):864-872. doi:10.1016/j.ekir.2019.03.016PubMedGoogle ScholarCrossref
BM , Akizawa
T , Jager
KJ , Kerr
PG , Saran
R , Pisoni
RL . Factors affecting outcomes in patients reaching end-stage kidney disease worldwide: differences in access to renal replacement therapy, modality use, and haemodialysis practices. Lancet
. 2016;388(10041):294-306. doi:10.1016/S0140-6736(16)30448-2PubMedGoogle ScholarCrossref
WL , Liu
J , Weinhandl
E , Fan
Q . A comparison of sevelamer and calcium-based phosphate binders on mortality, hospitalization, and morbidity in hemodialysis: a secondary analysis of the Dialysis Clinical Outcomes Revisited (DCOR) randomized trial using claims data. Am J Kidney Dis
. 2008;51(3):445-454. doi:10.1053/j.ajkd.2007.12.002PubMedGoogle ScholarCrossref