hyperphosphatemia chronic kidney disease (CKD)
Conditions
Interventions
administration of ferric citrate for two years (daily dosage: 500-1500 mg)
control group
Sponsors
Department of Internal medicine, Teikyo University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: patients with estimated glomerular filtration rates (eGFR) >=15 to 45 mL/min/1.73 m2 and serum phosphate levels >=4.0 mg/dL patients with no acute change of renal function
Exclusion criteria
Exclusion criteria: 1. Administration contraindication of ferric citrate 2. History of hypersensitivity to ferric citrate 3. Iron excess such as hemochromatosis 4. Uncontrolled diabetes mellitus; HbA1c >=9.0 % (NGSP) 5. Uncontrolled hypertension; systolic blood pressure >=170 mmHg or diastolic blood pressure >=110 mmHg 6. Acute renal failure, nephrotic syndrome, dialysis, or renal transplantation 7. Complication or history of malignant tumor (not excluded from the study when the malignant tumor is not treated within 5 years and if there is no recurrence) 8. Pregnancy, nursing, or planned pregnancy during the study 9. Hormone replacement therapy with estrogens during the study 10. Intake of activated vitamin D or cinacalcet at the confirmation of eligibility 11. Ineligibility at the investigator's discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change from baseline in eGFR after 6, 12, 18, 24 months of follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| the time from randomization to the event of 30% decline in eGFR and the amount of change in serum phosphate, FGF23, intact PTH, calciprotein particles, ferritin, hemoglobin levels and the urinary phosphate levels | — |
Countries
Japan
Contacts
Public ContactShunya Uchida
Teikyo University School of Medicine Department of Internal medicine
Outcome results
None listed