腹膜透析患者における貧血の治療のための鉄イソマルトシド

Inclusion Criteria:

1. Males or females who are ≥ 18 years and on PD treatment for ≥90 days, body weight≥50Kg
2. Hemoglobin(Hb）≤110 g/L at screening phase
3. Serum ferritin(SF）≤200 μg/L or transferrin saturation(TSAT）≤20% at screening phase
4. No oral or intravenous iron use within 4 weeks prior to screening.
5. No hypoxia-inducible factor prolyl hydroxylase inhibitor（HIF-PHI）used or other erythropoiesis-stimulating agent（ESA）except for erythropoietin (EPO) used in the past 4 weeks prior to screening
6. Stable doses of erythropoiesis-stimulating agents (ESA) with a change of dose ≤20% during the past 4 weeks.
7. Willing to participate and signed the informed consent form

Exclusion Criteria:

1. Anemia predominantly caused by other diseases rather than renal diseases according to the investigator's judgement. (eg. bleeding, hematological diseases, anemia due to autoimmune diseases)
2. History of disturbances in iron utilisation.(eg. hemochromatosis and hemosiderosis）
3. Anemia due to lack of folate or vitamin B12：folate<6.8nmol/L（3ng/ml）and(or) Vitamin B12<74pmol/L（100pg/ml）at screening phase
4. Histories of serious allergies to iron
5. Obvious liver dysfunction：ALT>3×ULN and/or AST>3×ULN，or total bilirubin>1.5×ULN
6. Active acute or chronic infection(clinically diagnosed)
7. Uncontrolled secondary hyperparathyroidism：PTH or iPTH>9×ULN；
8. History of malignancy within 5 years
9. Acute coronary syndrome, strokes (except for lacunar cerebral infarction), serious thromboembolism (eg. DVT or PE) within 6 months before the screening period
10. NYHA grade III or IV of congestive heart failure or severe arrythmia(including ventricular tachycardia, ventricular fibrillation, AV-block III etc.) within 6 months before screening
11. Pregnant or during lactation period or not willing to get contraception
12. Planning to receive renal transplantation within 2 months
13. Accepted blood transfusion within 3 months.
14. Serum ferritin，SF>500 μg/L
15. Planning to recieve the treatment as operations, chemotherapies or radiotherapies etc. during the research period
16. Other situations not suitable for inclusion decided by researchers. Rescreening is allowed if it failed in the first time of screening.