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NCT Number: NCT01578200

Outcome Study of Lanthanum Carbonate Compared With Calcium Carbonate in Hemodialysis Patients : Landmark Study

The purpose of this study is to demonstrate decrease in cardiovascular mortality and morbidity in Japanese hemodialysis patients treated with Lanthanum carbonate compared with those with Calcium carbonate.

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Key information

Conditions

Hemodialysis Avitaminosis Bone Diseases Bone Diseases, Metabolic Calcinosis Calcium Metabolism Disorders Chronic Disease Chronic Kidney Disease-Mineral and Bone Disorder Deficiency Diseases Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperparathyroidism Hyperparathyroidism, Secondary Hyperphosphatemia Kidney Diseases Male Urogenital Diseases Malnutrition Metabolic Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Parathyroid Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Phosphorus Metabolism Disorders Rickets Urogenital Diseases Urologic Diseases Vascular Calcification Vitamin D Deficiency

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Showa University

Shinagawa, Tokyo, 142-0064, Japan

About this study

Elevated serum phosphate and calcium in dialysis patients are independently associated with increased risk of arterial calcification and mortality. Calcium-based phosphate binders can induce hypercalcaemia and are associated with progression of vascular calcification. A recent randomized study demonstrated that sevelamer, a non-calcium-based phosphate binders, reduced mortality in elderly hemodialysis patients compared with calcium-based phosphate binders. Lanthanum carbonate is another efficacious and well-tolerated non-calcium phosphate binder. A post-hoc survival analysis of lanthanum carbonate versus standard therapy suggested a survival benefit of lanthanum carbonate treatment for elderly patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • hemodialysis patients with hyperphosphatemia who require phosphate binders
  • hemodialysis for more than 3 months
  • patients who have at least one calcification risk factor (elderly > 65 years, postmenopausal woman, type 2 diabetes mellitus)
  • intact-PTH < or = 240pg/mL
  • life expectancy > 1 year
  • with written informed consent

Exclusion criteria

  • contraindications to lanthanum carbonate and calcium carbonate
  • swallowing disorders
  • severe GI disorders
  • history of obstructed bowels
  • history of IHD/stroke within 6 months before randomization
  • NYHA classification Ⅲ-Ⅳ
  • severe liver dysfunction (AST or ALT greater than 3 times the upper limit of institution
  • require treatment of arrhythmia
  • severe malnutrition
  • malignancy of any type within the last five years
  • peritoneal dialysis patients
  • pregnant or possibly pregnant women or women on lactation and planned to get pregnant within study term
  • ineligible patients according to the investigator's judgment

Treatment and study plan

Lanthanum carbonate

Drug

Calcium Carbonate

Drug

Primary outcomes

  1. Cardiovascular event free survival time.

    Time frame: 3 years

    Cardiovascular event consisting of

    • death due to cardiovascular diseases including sudden cardiac death (ICD-10 codes R96.0/96.1),
    • nonfatal myocardial infarction,
    • nonfatal cerebral stroke including transient ischemic attack, TIA,
    • unstable angina,
    • hospitalization for heart failure,
    • hospitalization for ventricular arrhythmia

Secondary outcomes

  1. Overall survival

    Time frame: 3 years

  2. Secondary hyperparathyroidism free survival

    Time frame: 3 years

  3. Hip fracture free survival

    Time frame: 3 years

  4. Quality of life questionnaire (KDQOL-SF, v1.3)

    Time frame: 3 years

  5. Bone mineral density (DEXA)

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Other

Collaborators

  • Showa University School of Medicine

Registry information

Official study title

Outcome Study of Lanthanum Carbonate Compared With Calcium Carbonate on Cardiovascular Mortality and Morbidity in Patients With Chronic Kidney Disease on Hemodialysis (CKD5D)

Acronym: LANDMARK

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Apr 16, 2012
Registry last updated
Nov 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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