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Iron Isomaltoside for the Treatment of Anemia in Peritoneal Dialysis Patients
Sponsor: Xie Jingyuan, MD
Summary
This is a prospective multicenter randomized controlled clinical study. The goal of this clinical trial is to learn if intravenous iron isomaltoside injection use is equally effective and safe for the treatment of renal anemia in peritoneal dialysis patients compared with oral ferrous succinate tablets. The main questions to answer are: * Changes in hemoglobin concentration from baseline to week 8 after the use of single dose intravenous iron isomaltoside injection in peritoneal dialysis patients with renal anemia. * If intravenous iron isomaltoside injection use is equally effective and safe for the treatment of renal anemia in peritoneal dialysis patients compared with oral ferrous succinate tablets. Participants will: * be randomized 1:1 to two groups, either Iron isomaltoside Group (Group A, experimental group) or Ferrous succinate Group (Group B, control group). * Patients in Iron isomaltoside Group will receive a single dose of intravenous iron isomaltoside injection, the dose of which is set at 1000 mg. Patients in Ferrous succinate Group will receive ferrous succinate treatment orally given as 200mg twice a day for 8 weeks (containing iron element 7840mg in total). * Patients will be followed up for 8 weeks.
Official title: Efficacy and Safety of Iron Isomaltoside in the Treatment of Peritoneal Dialysis Patients with Renal Related Anemia: a Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
124
Start Date
2025-02-15
Completion Date
2027-12-31
Last Updated
2025-02-17
Healthy Volunteers
No
Conditions
Interventions
Iron isomaltoside
Intravenous infusion of 1000mg iron isomaltoside as a single dose for over 15min. Iron isomaltoside 1000mg was diluted in 100ml of 0.9% saline.
Ferrous succinate
Patients received ferrous succinate treatment orally given as 200mg twice a day for 8 weeks.