hyperphosphatemia
Conditions
Interventions
Sucroferric oxyhydroxide 750 to 3,000mg/day 12months medication Serum phosphorus value treatment goal 6.0mg/dL less than 5.0mg/dL or more
Lanthanum carbonate 750 to 2,250mg/day 12months medication
Sponsors
Osaka University Graduate School of Medicine Department of Nephrology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients with hyperphosphatemia in chronic maintenance dialysis. 2.Patients of the following serum P concentration before dialysis in observation period. In the case of patients with medication, the phosphorus adsorbent in the observation period is serum P concentration of 5.0mg/dL or more. In the case of patients with not medication, the phosphorus adsorbent in the observation period is serum P concentration of 6.1mg/dL or more. 3.Patients have elapsed dialysis after more than three months 4.Patients have received three times a week or more of stable hemodialysis (HD or HDF), and patients will continue to similar blood dialysis until the end of the treatment period start. 5.CACS of a patient is more than 30 that is measured during the observation period. 6.Patients are older 20-year-old or less than 80-year-old. 7.Outpatients 8.Gender does not matter. 9.Patients were obtained informed consent.
Exclusion criteria
Exclusion criteria: 1.Before dialysis, serum intact-PTH concentration of previously registered one month is exceeds 800 pg/mL or over 500pg/mL, it is determined that the uncontrolled. 2.Patients have hemochromatosis or patients have a history of other iron storage disorders, or serum ferritin concentration before dialysis of the observation period at the start is over 300ng/mL or TSAT is more than 50%. 3.Patients have severe liver dysfunction (C chronic hepatitis, etc.). 4.Patients have severe coronary artery disease 5.Patients are merged malignant tumor. 6.Patients are paroxysmal nocturnal hemoglobinuria. 7.Patients have hypersensitivity iron-containing formulations or lanthanum-containing formulations. 8.Patients received PTX. 9.Patients suspect of being pregnant or pregnant. 10.Research investigators or research sharing investigators have determined to the patient is inappropriate as a subject of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the rate of change of coronary artery calcification index at the start and after 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. changes in CACS, 2. changes in serum phosphate and calcium levels,changes in calcium phosphate product, and the ratio of patients who reached the target serum phosphate level, 3. changes in the level of intact parathyroid hormone (PTH), intact fibroblast growth factor (FGF)-23, and c-terminalFGF23, 4. effects on the renal anemia, assessed by transferrin saturation(TSAT), hemoglobin, and the changes in the dose of iron and EPO administration, 5. relationship between serum phosphate level and CACS, 6. average doses of phosphate binder required to achieve the target serum phosphate level, 7. safety issue (adverse drug reactions). | — |
Countries
Japan
Contacts
Public ContactToshihide Oshima
The Japan Clinical Research Forum Secretariat
Outcome results
None listed