Bixalomer versus calcium carbonate on coronary artery calcification in hemodialysis patients with hyperphosphatemia: a randomized study.
- Conditions
- endstage kidney disease on hemodialysis
- Registration Number
- JPRN-UMIN000013146
- Lead Sponsor
- CKD-MBD Clinical Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 300
Not provided
1.Serum phosphate level 8.0mg/dL or more 2.Bowel obstruction 3. Severe chronic constipation or diarrhea 4. A history of gastrointestinal ulcer or bowel resection 5. Hypothyroidism 6. Severe cardiac disease (NYHA classification III-IV or wide range of old myocardial infarction) 7. A history of hospitalization for cerebrovascular or cardiovascular disease within a month 8. Liver dysfunction (AST or ALT more than 2-times the upper limit of institution, or T-Bil more than 1.5-times the upper limit of institution) or severe liver disorders (active chronic hepatitis) 9. Pregnant, women on lactation or possibly pregnant women, or plan to get pregnant during the study 10. Having a disadvantage for CT scan (pacemaker, artificial valve, coronary artery stent, atrial fibrillation, etc.) 11. Ineligible patients according to the investigator's judgment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in coronary artery calcification score (CACs) by multi-detector CT
- Secondary Outcome Measures
Name Time Method 1. Change in serum phosphate and corrected serum calcium 2. Change in intact PTH 3. Change in serum FGF23 4. Change in serum alfa-Klotho 5. Change in serum pentosidine 6. Change in serum hs-CRP 7. Change in serum LDL-C 8. Change in serum NT-proBNP 9. cardiovascular event-free survival rate