Iron Isomaltoside for the Treatment of Anemia in Peritoneal Dialysis Patients

Launched by XIE JINGYUAN, MD · Feb 13, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at whether an injection of a medication called iron isomaltoside is as effective and safe as taking iron tablets (ferrous succinate) for treating anemia in patients who are on peritoneal dialysis. Anemia is a condition where you have low levels of hemoglobin, which is important for carrying oxygen in your blood. The study will compare how well each treatment works over an 8-week period by measuring changes in hemoglobin levels.

To participate in this trial, you need to be at least 18 years old, have been receiving peritoneal dialysis for at least 90 days, and have low hemoglobin levels (110 g/L or less) as well as low iron stores. You should not have taken any iron supplements or certain other medications in the month before the trial starts. If you join, you will be randomly assigned to receive either the iron injection or the iron tablets. Throughout the 8 weeks, you'll have regular check-ins to monitor your health and how well the treatment is working.

Gender

ALL

Eligibility criteria

• 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.