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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hemodialysis, Hyperphosphatemia

Intervention / Treatment
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* Drug: Lanthanum Carbonate
* Drug: Calcium Carbonate


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lanthanum carbonate<br>Patients are given Lanthanum Carbonate oral administration after meals three times per day in total daily dose of 750-2250mg. | Drug: Lanthanum Carbonate<br> <br> |
| Active Comparator: Calcium Carbonate<br>Patients are given Calcium carbonate oral administration after meals three times per day in total daily dose of 3.0g. | Drug: Calcium Carbonate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular event free survival time. | 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 | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 3 years | 
| Secondary hyperparathyroidism free survival |  | 3 years | 
| Hip fracture free survival |  | 3 years | 
| Quality of life questionnaire (KDQOL-SF, v1.3) |  | 3 years | 
| Bone mineral density (DEXA) |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CKD-MBD, phosphate-binder, vascular calcification, mortality, dialysis, Hemodialysis patients with hyperphosphatemia