Outcome Study of Lanthanum Carbonate Compared With Calcium Carbonate in Hemodialysis Patients : Landmark Study (LANDMARK)
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ClinicalTrials.gov Identifier: NCT01578200 |
Recruitment Status :
Completed
First Posted : April 16, 2012
Last Update Posted : November 30, 2020
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Condition or disease | Intervention/treatment | Phase |
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Hemodialysis Hyperphosphatemia | Drug: Lanthanum Carbonate Drug: Calcium Carbonate | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2309 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Outcome Study of Lanthanum Carbonate Compared With Calcium Carbonate on Cardiovascular Mortality and Morbidity in Patients With Chronic Kidney Disease on Hemodialysis (CKD5D) |
Study Start Date : | December 24, 2011 |
Actual Primary Completion Date : | March 25, 2019 |
Actual Study Completion Date : | March 25, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Lanthanum carbonate
Patients are given Lanthanum Carbonate oral administration after meals three times per day in total daily dose of 750-2250mg.
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Drug: Lanthanum Carbonate |
Active Comparator: Calcium Carbonate
Patients are given Calcium carbonate oral administration after meals three times per day in total daily dose of 3.0g.
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Drug: Calcium Carbonate |
- 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
- Overall survival [ Time Frame: 3 years ]
- Secondary hyperparathyroidism free survival [ Time Frame: 3 years ]
- Hip fracture free survival [ Time Frame: 3 years ]
- Quality of life questionnaire (KDQOL-SF, v1.3) [ Time Frame: 3 years ]
- Bone mineral density (DEXA) [ Time Frame: 3 years ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01578200
Japan | |
Showa University | |
Shinagawa, Tokyo, Japan, 142-0064 |
Principal Investigator: | Tadao Akizawa, MD, PhD | Showa University |
Responsible Party: | Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan |
ClinicalTrials.gov Identifier: | NCT01578200 |
Other Study ID Numbers: |
TRIGU1111 UMIN000006815 ( Registry Identifier: UMIN Clinical Trials Registry ) |
First Posted: | April 16, 2012 Key Record Dates |
Last Update Posted: | November 30, 2020 |
Last Verified: | March 2019 |
CKD-MBD phosphate-binder vascular calcification |
mortality dialysis Hemodialysis patients with hyperphosphatemia |
Hyperphosphatemia Phosphorus Metabolism Disorders Metabolic Diseases Calcium Carbonate Calcium |
Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Antacids Molecular Mechanisms of Pharmacological Action Gastrointestinal Agents |