Iron Isomaltoside for the Treatment of Anemia in Peritoneal Dialysis Patients

This is a prospective multicenter randomized controlled clinical study. The purpose of this study is to evaluate the efficacy and safety of single dose intravenous iron isomaltoside comparing with daily oral ferrous succinate in the treatment of renal anemia among patients on peritoneal dialysis.

A total of 124 patients will be enrolled. The primary endpoint is hemoglobin change from baseline to week 8, the secondary endpoint is hemoglobin change from baseline to week 4. Other secondary endpoints include the results of iron metabolism, reticulocytes, composite cardiovascular events, laboratory and safety parameters. The expected result is that intravenous iron isomaltoside is equally effective and safe for the treatment of renal anemia in peritoneal dialysis patients compared with oral ferrous succinate tablets.

Inclusion criteria

• Males or females who are ≥ 18 years and on PD treatment for ≥90 days, body weight≥50Kg
• Hemoglobin(Hb）≤110 g/L at screening phase
• Serum ferritin(SF）≤200 μg/L or transferrin saturation(TSAT）≤20% at screening phase
• No oral or intravenous iron use within 4 weeks prior to screening.
• 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
• Stable doses of erythropoiesis-stimulating agents (ESA) with a change of dose ≤20% during the past 4 weeks.
• Willing to participate and signed the informed consent form

Exclusion criteria

• 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)
• History of disturbances in iron utilisation.(eg. hemochromatosis and hemosiderosis）
• 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
• Histories of serious allergies to iron
• Obvious liver dysfunction：ALT>3×ULN and/or AST>3×ULN，or total bilirubin>1.5×ULN
• Active acute or chronic infection(clinically diagnosed)
• Uncontrolled secondary hyperparathyroidism：PTH or iPTH>9×ULN；
• History of malignancy within 5 years
• Acute coronary syndrome, strokes (except for lacunar cerebral infarction), serious thromboembolism (eg. DVT or PE) within 6 months before the screening period
• 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
• Pregnant or during lactation period or not willing to get contraception
• Planning to receive renal transplantation within 2 months
• Accepted blood transfusion within 3 months.
• Serum ferritin，SF>500 μg/L
• Planning to recieve the treatment as operations, chemotherapies or radiotherapies etc. during the research period
• Other situations not suitable for inclusion decided by researchers. Rescreening is allowed if it failed in the first time of screening.