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

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Hemodialysis; Hyperphosphatemia	Drug: Lanthanum Carbonate; Drug: Calcium Carbonate	Phase 3

Detailed Description:

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.

Study Design

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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 2011
Estimated Primary Completion Date :	June 2017
Estimated Study Completion Date :	June 2017

Arms and Interventions

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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.	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.	Drug: Calcium Carbonate

Outcome Measures

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Primary Outcome Measures :

1. Cardiovascular event free survival time. [ Time Frame: 3 years ]

   Cardiovascular event consisting of

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

Secondary Outcome Measures :

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 ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

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Locations

Japan
Showa University
Shinagawa, Tokyo, Japan, 142-0064

Sponsors and Collaborators

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

Showa University School of Medicine

Investigators

Principal Investigator:	Tadao Akizawa, MD, PhD	Showa University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier:	NCT01578200 History of Changes
Other Study ID Numbers:	TRIGU1111; UMIN000006815 ( Registry Identifier: UMIN Clinical Trials Registry )
First Posted:	April 16, 2012
Last Update Posted:	September 28, 2016
Last Verified:	September 2016

Keywords provided by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan:

CKD-MBD; phosphate-binder; vascular calcification	mortality; dialysis; Hemodialysis patients with hyperphosphatemia

Additional relevant MeSH terms:

Hyperphosphatemia; Phosphorus Metabolism Disorders; Metabolic Diseases; Calcium, Dietary; Calcium Carbonate	Bone Density Conservation Agents; Physiological Effects of Drugs; Antacids; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents