endstage kidney disease on hemodialysis
Conditions
Interventions
Bixalomer treatment (Follow-up: a year)
Calcium carbonate treatment (Follow-up: a year)
Sponsors
CKD-MBD Clinical Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with chronic kidney disease on hemodialysis who have been receiving calcium carbonate treatment for more than 3 months 2)Age 20 years or older at the time of giving informed consent 3)Ability to give written informed consent
Exclusion criteria
Exclusion criteria: 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 ofinstitution) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in coronary artery calcification score (CACs) by multi-detector CT | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactTakashi Akiba
Tokyo Women's Medical University Department of Blood Purification, Kidney
Outcome results
None listed