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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,309
Showa University
Shinagawa, Tokyo, Japan
Cardiovascular event free survival time.
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
Time frame: 3 years
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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