Hemodialysis, Hyperphosphatemia
Conditions
Keywords
CKD-MBD, phosphate-binder, vascular calcification, mortality, dialysis, Hemodialysis patients with hyperphosphatemia
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.
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.
Interventions
DRUGLanthanum Carbonate
DRUGCalcium Carbonate
Sponsors
Showa University School of Medicine
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular event free survival time. | 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
| Measure | 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 |
Countries
Japan
Outcome results
None listed