title: Design and baseline characteristics of the LANDMARK study.
abstract: BACKGROUND
  Calcium (Ca)-based phosphate (P) binders, compared to non-Ca-based P binders, contribute to vascular calcification, which is associated with cardiovascular events.
  
  
  METHODS
  The LANDMARK study is a multicenter, randomized, open-label, parallel comparative study of lanthanum carbonate (LC) and calcium carbonate (CC) in hemodialysis patients. Stable hemodialysis patients with intact parathyroid hormone ≤240 pg/mL meeting ≥1 of the following criteria (age >65 years, postmenopause, diabetes mellitus) were randomized into the LC and CC groups. LC group patients initially received LC 750 mg/day or the previously used dose and were titrated up to a maximum 2250 mg/day to achieve serum P levels of 3.5-6.0 mg/dL. CC group patients received CC 3 g/day or the previously used dose and were titrated to achieve the same P range. If the target serum P level was not achieved, non-Ca-based P binders (other than LC) could also be added. The primary endpoint is survival time free of cardiovascular events, including cardiovascular death, non-fatal myocardial infarction or stroke, and unstable angina.
  
  
  RESULTS
  Overall, 2309 patients were allocated to the LC (N = 1154) or CC group (N = 1155). At baseline, the mean age was 68.4 years, 40.4 % were women, 55.9 % had diabetes, 18.3 % had a history of ischemic heart disease, and 13.9 % had cerebrovascular disease. A total of 184 patients (8.4 %) had undergone coronary intervention procedures. Baseline characteristics were well balanced between groups.
  
  
  CONCLUSIONS
  The LANDMARK study will determine whether LC, a non-Ca-based P binder, reduces cardiovascular mortality and morbidity in chronic hemodialysis patients.
authors.affiliation: Department of Internal Medicine, Showa University Northern Yokohama Hospital, 35-1 Chigasaki-chuo, Tsuzuki-ku, Yokohama, Kanagawa, 224-8503, Japan. ogatah@med.showa-u.ac.jp.
authors.forename: Hiroaki
authors.identifier: http://orcid.org/0000-0002-0046-5575
authors.initials: H
authors.lastname: Ogata
authors.affiliation: Division of Nephrology, Endocrinology and Metabolism, Tokai University School of Medicine, Isehara, Kanagawa, Japan.
authors.forename: Masafumi
authors.initials: M
authors.lastname: Fukagawa
authors.affiliation: Division of Nephrology and Dialysis Center, Japanese Red Cross Fukuoka Hospital, Fukuoka, Fukuoka, Japan.
authors.forename: Hideki
authors.initials: H
authors.lastname: Hirakata
authors.affiliation: Translational Research Informatics Center, Kobe, Hyogo, Japan.
authors.forename: Hideaki
authors.initials: H
authors.lastname: Kaneda
authors.affiliation: Translational Research Informatics Center, Kobe, Hyogo, Japan.
authors.forename: Tatsuo
authors.initials: T
authors.lastname: Kagimura
authors.affiliation: Division of Nephrology, Department of Medicine, Showa University School of Medicine, Sinagawa-ku, Tokyo, Japan.
authors.forename: Tadao
authors.initials: T
authors.lastname: Akizawa
mesh_terms: D000368:Aged; D015415:Biomarkers / Q000097:blood; D002119:Calcium Carbonate / Q000009:adverse effects / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000097:blood / Q000401:mortality; D002614:Chelating Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002985:Clinical Protocols; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D054559:Hyperphosphatemia / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D007564:Japan; D007811:Lanthanum / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010710:Phosphates / Q000097:blood*; D006435:Renal Dialysis / Q000009:adverse effects / Q000401:mortality; D051436:Renal Insufficiency, Chronic / Q000097:blood / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D012107:Research Design; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D002614:Chelating Agents; D010710:Phosphates; C119467:lanthanum carbonate; D007811:Lanthanum; D002119:Calcium Carbonate
keywords: Calcium; Cardiovascular event; Hemodialysis; Phosphate binder; Randomized controlled trial